Devices, systems, and methods for performing atherectomy including delivery of a bioactive material

ABSTRACT

Devices, systems, and methods are employed to perform an atherectomy in an identified region to restore patency to arterial lesions. A bioactive material is introduced into the identified region before, after or during performing the atherectomy. The bioactive material can be introduced, e.g., on a balloon coated with the bioactive material, which is expanded in contact with the identified region to deliver the bioactive material. The bioactive material can be, e.g., at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/932,371, filed Feb. 24, 2011 and titled “Devices, Systems, andMethods for Performing Atherectomy Including Delivery of a BioactiveMaterial,”which is a divisional of co-pending U.S. patent applicationSer. No. 12/215,752, filed Jun. 30, 2008 and entitled “AtherectomyDevices, Systems, and Methods,”which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/043,998, filed Apr. 10, 2008,and entitled “Atherectomy Devices and Methods,”which is incorporatedherein by reference.

U.S. application Ser. No. 12/215,752 also claims the benefit of U.S.Provisional Patent Application Ser. No. 60/981,735, filed Oct. 22, 2007,and entitled “Atherectomy Devices and Methods,”which is incorporatedherein by reference.

U.S. application Ser. No. 12/215,752 is also a continuation-in-part ofco-pending U.S. patent application Ser. No. 11/771,865, filed Jun. 29,2007, and entitled “Atherectomy Devices and Methods,”which is acontinuation-in-part of co-pending U.S. patent application Ser. No.11/567,715, filed Dec. 6, 2006, and entitled “Atherectomy Devices andMethods,”which is a continuation of co-pending U.S patent applicationSer. No. 11/551,191, filed Oct. 19, 2006, and entitled “AtherectomyDevices and Methods,”which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/806,417, filed Jun. 30, 2006 and which alsoclaims the benefit of U.S. Provisional Patent Application Ser. No.60/820,475, filed Jul. 26, 2006, and entitled “Atherectomy Device,”whichare all incorporated herein by reference.

FIELD OF THE INVENTION

The devices, systems, and methods generally relate to treatment ofoccluded body lumens, e.g., for removal of occluding material from ablood vessel as well as other body parts.

BACKGROUND OF THE INVENTION

I. Peripheral Arterial Disease

Peripheral Arterial Disease (PAD) is a progressive disease. In thisdisease, lesions of the arteries are formed by accumulation of plaqueand neointimal hyperplasia causing an obstruction of blood flow. Plaque(the build-up of cholesterol, cells, and other fatty substances) isoften friable and may dislodge naturally or during an endovascularprocedure, possibly leading to embolization of a downstream vessel.

It is estimated that 12 million people in the United States suffer fromPAD that if left untreated has a mortality rate of 30 percent at fiveyears. There are approximately 160,000 amputations each year fromcritical limb ischemia, the most severe subset of patients having PAD.The prevalence of PAD is on the rise, with risk factors including age,obesity, and diabetes.

Endovascular clearing procedures to reduce or remove the obstructions torestore luminal diameter and allow for increased blood flow to normallevels are known. Removing the plaque has the effect of removingdiseased tissue and helps to reverse the disease. Maintaining luminaldiameter for a period of time (several to many weeks) allows remodelingof the vessel from the previous pathological state to a more normalstate. It is also the goal of an endovascular clearing procedure toprevent short term complications such as embolization or perforation ofthe vessel wall, and long term complications such as ischemia fromthrombosis or restenosis.

II. Prior Treatment Modalities

Online coronary artery disease, current treatment options for PAD,including PAD in the arteries of the leg, have significant limitationsfor at least three main reasons: A) large volumes of plaque build up invery long, diffuse lesions, B) low blood flow promotes thrombusformation and plaque buildup, and C) arteries of the leg are bent,twisted, stretched, and pinched shut during routine movement.

Various treatment modalities have been tried to accomplish treatmentgoals. In atherectomy, plague is cut away, or excised. Variousconfigurations have been used including a rotating cylindrical shaver ora fluted cutter. The devices may include some form of shielding by ahousing for safety purposes. The devices may incorporate removal ofdebris via trapping the debris in the catheter, in a downstream filter,or aspirating the debris, for example. In some cases a burr may be usedinstead of a cutter, particularly to grind heavily calcified lesionsinto very small particle sizes. Aspiration may also be used with aburr-type atherectomy device.

A current example of an atherectomy device is the SilverHawk® PlaqueExcision System by Fox Hollow Technologies. The SilverHawk has a numberof limitations including the length of time the procedure takes to cleara lumen, it requires multiple devices and repeated catheter exchanges,it produces embolic debris, and it uses an unguarded cutter design thatrequires great patience and care to open the lumen while sparing thevessel wall. In use, the physician advances the catheter through thelesion, shaving plaque off of the artery walls and collecting the plaquein a long receptacle (nosecone) at the tip of the catheter (which musthave enough room in the vessel to pivot to access the cutting blade). Asthe receptacle fills, the catheter must be removed, the receptacleemptied, and the procedure repeated until enough plaque is removed torestore normal blood flow. The procedure may include replacing thecatheter with a larger diameter catheter to expand the size of theclearing. The long receptacle at the tip of the catheter limits the useof the device to mainly straight lumens.

Balloon angioplasty is another type at endovascular procedure. Balloonangioplasty expands and opens the artery by both displacing the plaqueand compressing it by expanding a balloon in the artery, with somevariations including a drug coated balloon. Balloon angioplasty is knownto cause barotrauma to the vessel from the high pressures required tocompress the plaque, and can also cause dissection of the vessel wall.This trauma leads to an unacceptably high rate of restenosis.Furthermore, this procedure may not be efficient for treatment ofelastic-type plaque tissue, where such tissue can spring back to occludethe lumen.

Cryoplasty has been available for only a few years and has provided onlylimited positive results. With cryoplasty, the main problem appears tobe restenosis after an extended period, such as a year. The technique issimilar to balloon angioplasty procedures used in heart vessels, exceptstents are not used to keep the blood vessel open. With cryoplasty, theballoon is cooled to about −10 degrees Celsius (14 degrees Fahrenheit)by evaporating liquid nitrous oxide into a gas upon entering theballoon. The plaque clogging the artery cracks when it freezes, allowingfor a more uniform dilation of the blood vessel than occurs in astandard angioplasty procedure.

Various forms of laser atherectomy have been developed and have hadmixed results. One main limitation of a laser system is that the lasercan only be effectively used in a straight lumen, and is less effectivein or around tortuous lumens. When the laser is in position, it emitspulsating beams of light that vaporize the plaque. Laser systems havebeen less effective for removing calcified legions because of the laserproperties.

Stenting may also be used as a treatment option. On their own, stents,including drug eluding stents, fail to perform well in the peripheralvasculature for a variety of reasons. A stent with the necessarystructural integrity to supply sufficient radial force to reopen theartery often does not perform well in the harsh mechanical environmentof the peripheral vasculature. For example, the peripheral vasculatureencounters a significant amount of compression, torsion, extension, andbending. Such an environment may lead to stent failure (strut fracture,stent crushing, etc.) that eventually compromises the ability of thestent to maintain lumen diameter over the long-term. Stenting is alsosusceptible to in-stent restenosis, typically at a restenosis rate of 30percent or higher. Stent fracture or restenosis may require subsequentvascular bypass surgery, which is invasive and is limited in the typesof lesions or artery obstructions that may produce acceptable results.Stenting is not advisable in regions which would be candidates forproximal or distal anastamosis during surgical bypass procedures,because a stent in that region makes bypass difficult or impossible.

On the other hand, a stent that is able to withstand the harshmechanical aspects of the periphery often will not supply enough radialforce to open the vessel satisfactorily. In many cases, medicalpractitioners desire the ability to combine endovascular clearingprocedures with stenting. Such stenting may occur prior to, after, orboth before and after the endovascular clearing procedure.

Accordingly, a need remains for devices, systems, and methods that allowfor improved atherectomy systems that are able to navigate throughtortuous anatomy and clear materials from body lumens (such as bloodvessels) where the systems includes features to allow for a safe,efficient and controlled fashion of shaving or grinding material withinthe body lumen while minimizing procedure times. In addition, thereremains a need for systems that allow steering of the distal portion ofthe system while navigating through tortuous anatomy. The ability tosteer assists the physician in accessing tortuous anatomy and canfurther assist in delivering a guidewire into the entrance of angled ortortuous vessel bifurcation/segments. This is possible becausevariations of the steerable atherectomy catheter system described hereincan also function as a ‘shuttle catheter’, where the physician can aimthe distal tip into the vessel to be accessed and advancing theguidewire into that vessel from within the catheter

There also remains a need for devices that are configured to steer butwill remain in a straight configuration when not being articulated. Itis generally known that conventional catheters that take a shape oftenbias to one side either through repeated articulation or even afterbeing left in packing for any given period of time. Accordingly, whensuch steering features are combined with tissue debulking systems, thereremains a risk of injury if the tissue debulking system has anundesirable bend when the device is intended to be in a straightconfiguration.

The debulking devices, systems, and methods described herein address theproblems noted above as well as provide significant improved features toallow a physician to steer a debulking device through tortuous anatomyand remove tissue at a target site.

SUMMARY OF THE INVENTION

One aspect of the invention provides a method for treating a region of ablood vessel. The method includes deploying a vascular device into aregion of a blood vessel having an occlusive material. The vasculardevice comprises a catheter body having at its distal end a cutterassembly. The cutter assembly comprises a housing having at least oneopening and a cutter having at least one helical cutting surfaceconfigured to rotate about the central axis relative to the housing tocut and convey occlusive material from the region proximally into thehousing. The vascular device also includes a drive mechanism at aproximal end of the catheter body, and a torque shaft coupled to thedrive mechanism and extending through the catheter body and coupled tothe cutter to rotate the helical cutting blade about the center axisrelative to the housing.

In one embodiment, the vascular device includes a conveyor mechanismhelically wound about the torque shaft in a direction common with thehelical cutting blade to rotate and thereby convey occlusive materialfrom the region further proximally along the catheter body for dischargewithout supplement of a vacuum pump. In this embodiment, the methodcomprises performing an atherectomy in the identified region byoperating the drive mechanism to rotate the helical cutting surface tocut and convey occlusive material from the identified region proximallyinto the housing, the drive mechanism also operating to rotate theconveyor mechanism to convey the occlusive material further proximallyalong the catheter body for discharge without supplement of a vacuumpump. The method can include visualizing the identified region before,during, and after performing the atherectomy.

In one embodiment, the vascular device includes a deflecting mechanismat the proximal end of the catheter body for deflecting the distal endof the catheter body relative to a center axis of the catheter body. Inthis embodiment, the method comprises performing an atherectomy in theidentified region by operating the drive mechanism to rotate the helicalcutting surface to cut and convey occlusive material from the identifiedregion proximally into the housing, and deflecting the distal end of thecatheter body relative to a center axis of the catheter body, androtating the distal end of the catheter body while the distal end isdeflected to sweep the cutter assembly in an arc about the center axisto cut the occlusive material in a region larger than an outsidediameter of the cutter assembly. The method can include visualizing theidentified region before, during, and after performing the atherectomy.

According to this aspect of the invention, in either embodiment, themethod includes introducing into the identified region a bioactivematerial before, after or during performing the atherectomy in theidentified region. Introducing the bioactive material can comprise,e.g., introducing into the identified region a balloon coated with abioactive material, and expanding the balloon in contact with theidentified region to deliver the bioactive material. The bioactivematerial can comprise, e.g., at least one of a restenosis-inhibitingagent, a thrombus-inhibiting agent, and an anti-inflammatory agent.

In one embodiment, the method further includes after conveying at leastsome of the occlusive material from the identified region, placing astent structure in the identified region. In one embodiment, afterplacing the stent structure, the method further includes performing anatherectomy to remove residual occlusive material from the stentstructure. In one embodiment, the method includes, after placing thestent structure, introducing a bioactive material into the stentstructure. The bioactive material can comprise, e.g., at least one of arestenosis-inhibiting agent, a thrombus-inhibiting agent, and ananti-inflammatory agent.

The blood vessel can comprise, e.g., a peripheral blood vessel, e.g., aperipheral blood vessel in a leg, or a peripheral blood vessel in a legbelow a knee.

As noted herein, combinations of aspects of the devices, systems, andmethods described herein may be combined as needed. Furthermore,combinations of the devices, systems and methods themselves are withinthe scope of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a system adapted for the removal ofoccluding material from body lumens according to the present invention.

FIG. 1B is a close up perspective view of the distal tip of the systemshown in FIG. 1A, showing an embodiment of a cutting assembly.

FIG. 2A is a perspective exploded view showing the cutting assembly ofFIG. 1B.

FIG. 2B is a perspective view of a two piece cutter shown in FIG. 2A.

FIGS. 3A to 3C show a cutter assembly having a dynamic housing where theexternal housing acts as a cutter in conjunction with an internal twoflute cutter.

FIG. 3D shows an exploded view of the cutter assembly of FIG. 3C.

FIG. 3E shows a perspective view of a cutter assembly with a dynamichousing removing material from a lumen wall.

FIGS. 4A and 4B shows placement of features of the cutter assembly thatprevent damage to the vessel walls.

FIG. 5A shows a perspective view of a variation of an open ended cutterhousing with an inner bevel.

FIG. 5B shows a cross sectional side view of the open ended cutter ofFIG. 5A taken along lines 5B-5B.

FIGS. 6A and 6B show variations of cutting assemblies for removingtissue from body lumens.

FIGS. 7A through 7F show additional variations for centering deviceswithin a lumen.

FIG. 8A is a perspective view in partial section of a distal portion ofa system adapted for the removal of occluding material from body lumens,showing an embodiment of a sweep sheath.

FIG. 8B is a perspective exploded view showing an additional embodimentof a cutting assembly with a one piece cutter.

FIG. 9 is a perspective exploded view showing an additional embodimentof a cutting assembly with a two piece cutter.

FIG. 10 shows a cross sectional view of the cutting assembly shown inFIG. 8A.

FIG. 11A shows the cutting edges through openings of a housing.

FIG. 11B shows a side view of the cutting assembly of FIG. 11A.

FIG. 11C shows a front view of the cutting assembly of FIG. 11A, andshowing a positive rake angle.

FIG. 12 is a perspective view of an embodiment of a guarded housinghaving a dilation member.

FIGS. 13A through 13C are side views showing the use of a debulkingdevice having a dilating member as seen in FIG. 12.

FIGS. 14A and 14B show an additional embodiment of a shielded cutterhaving a plurality of front cutting surfaces and fluted cuttingsurfaces.

FIG. 15 is a perspective view of a cutting assembly having a guardedhousing and incorporating a burr tip.

FIGS. 16A and 16B show a variation of a shielded cutter having aplurality of front cutting surfaces, rear cutting surfaces, and flutedcutting surfaces.

FIG. 17 is a perspective view in partial section of a distal portion ofa system adapted for the removal of occluding material from body lumens,showing the catheter body, a sweep sheath, a torque shaft, and aconveying member.

FIGS. 18A and 18B show additional possible variations a catheter body orsweep member.

FIG. 18C is a side view of an alternative embodiment of a catheter bodyincluding a multi-body design having minimal torsional losses whilemaximizing bending in a first portion and longitudinal stiffness in asecond portion.

FIG. 18D is a detail view of the first and second section of FIG. 18C,showing one embodiment of a dovetail design for the first section.

FIG. 18E is a detail view of an alternative embodiment of the firstsection of FIG. 18C, showing an additional embodiment of a dovetaildesign for the first section.

FIG. 18F is a side view of the catheter body including a multi-bodydesign of FIG. 18C, showing a flexed distal portion.

FIG. 19A shows a conveying member within the catheter body and sweepframe.

FIG. 19B shows an embodiment of a conveying member wound around thetorque shaft, as seen in FIG. 17.

FIG. 19C shows a partial cross sectional view of a variation of aconveying member and a torque shaft having counter wound coils.

FIG. 19D shows a second conveying member within a torque shaft.

FIG. 19E is a perspective view of an alternative torque shaft includinga wound groove as the conveying member.

FIG. 20A is a perspective view in partial section similar to FIG. 17,showing the sweep frame causing angular deflection of the distal portionof the catheter.

FIG. 20B is a side view of the distal portion of the catheter shown inFIG. 20A, with the sweep frame in an unflexed position.

FIG. 20C is a perspective view in partial section similar to FIG. 20A,showing a sweep member abutting the sweep frame, with the sweep framecausing angular deflection of the distal portion of the catheter, wherethe sweep frame is flexed or compressed to articulate the catheter up toa predefined angle.

FIGS. 21A through 21C show additional variations of sweep frames for usewith the debulking devices described herein.

FIG. 22A illustrates articulation of the distal portion of the catheteraround a tortuous bend to reach a lesion for removal.

FIG. 22B through 22D shows variations of sweeping of the cuttingassembly, with the sweep being able to rotate 360 degrees or more.

FIG. 22E a cross sectional view of a vessel, and showing the ability ofthe system to clear a lumen in a vessel up to four times the diameter ofthe catheter.

FIGS. 23A through 23H show the debulking system in use for both passiveand active steering through a tortuous vessel and to a treatment site.

FIGS. 24A through 24C illustrate the use of a debulking device to assistin the navigation of a guidewire through tortuous anatomy and occludingmaterial.

FIG. 24D shows placement of housing windows to prevent damage to thevessel walls, and apposition of the catheter against the vessel wall.

FIG. 25A shows an exploded view of a control handle for the debulkingsystem, the handle adapted for rotating and articulating the distalportion of the catheter, including the cutter assembly.

FIG. 25B is a side view in partial section showing the handle baseportion adapted to house functional elements of the control handle, andto isolate functions of the control handle from the catheter chassis.

FIGS. 26A through 26C show side views of the flexible distal portion ofthe catheter having an adjustable flexible distal length, and alsoadapted for orbital rotation possibly using an element of unbalance.

FIG. 27 is a perspective view of the catheter chassis portion adapted tosnap fit within the handle base portion, and including the controlmechanisms for steering and sweeping, irrigation, aspiration, androtation of the torque shaft.

FIGS. 28A and 28B an indexing cassette and associated spring plunger, asseen in FIG. 27, the indexing cassette and associated spring plungeradapted for fine tune control for cutter assembly deflection andsteering features.

FIGS. 29A and 29B show a debulking system, including a control handlefor the system, the handle adapted for rotating and articulating thedistal portion of the catheter, including the cutter assembly.

FIG. 30 shows a schematic view of the debulking system, the systemcutting debris, and aspirating the debris through the catheter, into thecatheter chassis, and out the aspiration port.

FIGS. 31A and 31B show variations of a sweep frame having avisualisation feature that permits a physician to determine orientationand direction of articulation of the cutting assembly when the device isviewed under non-invasive imaging.

FIGS. 32A through 32C provide examples of fluid delivery systems.

FIG. 33 shows a variation of a device configured for rapid exchange.

FIG. 34 illustrates an example of centering a tip of a cutting assemblyover a guide wire.

FIG. 35 shows a cutting assembly removing lesions within a stent orcoil.

FIG. 36 shows an anatomic view of the lower limb of an animal, includinga human, and showing a representation of the arteries within the lowerlimbs.

FIG. 37A shows an anatomic view similar to FIG. 36, and showing acontralateral configuration for a possible access site for the system tobe used in the vasculature for the removal of lesions.

FIG. 37B shows a detail view of FIG. 37A, the detail view showing thecatheter 120 extending through the external iliac artery, throughtortuous vessels, and into the profunda artery for debulking of anocclusion.

FIG. 38A shows an anatomic view similar to FIG. 35, and showing anadditional possible ipsilateral access site for the system to be used inthe vasculature for the removal of lesions.

FIG. 38B shows a detail view of FIG. 38A, the detail view showing thecatheter 120 extending through the popliteal femoral artery, throughtortuous vessels, and into the anterior tibial artery for debulking ofan occlusion.

FIG. 39 is a view of a set of components of the system consolidated foruse in a multiple piece kit, along with instructions for their use.

FIGS. 40A and 40B show a distal portion of a debulking catheterincluding a balloon or other mechanism for adjunctive angioplasty,stent, and/or other drug delivery.

FIGS. 41A and 41B are side views of an embodiment of a debulking system,the system including a transducer and/or sensor to provide imaging ofthe targeted treatment site before and/or after treatment.

FIG. 42 is a side view of an embodiment of a debulking system, thesystem including an imaging system at or near a distal end to provideimaging of the targeted treatment site before and/or after treatment.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

This specification discloses various catheter-based devices, systems,and methods for removing occluding materials from body lumens, includingremoving plaque, thrombus, calcium, and soft elastic tissues in bloodvessels. For example, the various aspects of the invention haveapplication in procedures requiring the treatment of diseased and/ordamaged sections of a blood vessel. The devices, systems, and methodsthat embody features of the invention are also adaptable for use withsystems and surgical techniques that are not necessarily catheter-based.

The devices, systems, and methods are particularly well suited forcontinuous debulking and aspiration of occluding material in theperipheral vasculature, including arteries found in the legs, such asthe common femoral artery, superficial femoral artery, profunda femorusartery, popliteal artery, and tibial artery, as non-limiting examples.For this reason, the devices, systems, and methods will be described inthis context. Still, it should be appreciated that the discloseddevices, systems, and methods are applicable for use in treating otherdysfunctions elsewhere in the body, which are not necessarilyartery-related.

When referring to catheter based apparatus or devices that aremanipulated by a physician or operator in order to remove occludingmaterials from a body lumen, the terms “proximal” and “distal” will beused to describe the relation or orientation of the apparatus or devicewith respect to the operator as it is used. Therefore, the term“proximal” will be used to describe a relation or orientation of theapparatus or device that, when in use, is positioned toward the operator(i.e., at the “handle” end of the device), and the term “distal” will beused to describe a position or orientation of the apparatus or devicethat, when in use, is positioned away from the operator (i.e., at the“cutter” end of a catheter or the like away from the handle).

When referring to plaque in a vessel, or a partial or complete blockagein a vessel or body organ, the terms “proximal” and “distal” will beused to describe the relation or orientation of the plaque or blockagewith respect to the heart. Therefore, the term “proximal” will be usedto describe a relation or orientation of the plague or blockage that istoward the heart, and the term “distal” will be used to describe aposition or orientation of the plaque or blockage that is away from theheart, i.e., toward the feet.

I. System Overview

A. System Capabilities

FIGS. 1A and 1B illustrate an exemplary variation of a system 100according to the present invention, the system 100 adapted forthrombectomy and/or atherectomy. As shown, the system 100 includes adistal cutter assembly 102 affixed to a catheter body or catheterassembly 120, with the catheter assembly coupled to a control handle 200at a proximal end. It is noted that the assemblies shown in the figuresare for exemplary purposes only. The scope of this disclosure includesthe combination of the various embodiments, where possible, as well asthe combination of certain aspects of the various embodiments.

The system 100 provides substantial ease of use, performance, and safetyadvantages over prior debulking types of devices. As will be describedin greater detail throughout this specification and Figures, the system100 may include 360 degree steerable rotational cutting, a guarded(shielded) or open cutter at the distal end of a catheter, with thecatheter coupled to a hand-held controller (i.e., handle) that isadapted to allow continuous debulking and aspiration of lesions rangingfrom fresh thrombus to calcified plaque. The debris is trapped withinthe catheter as it is cut, and may be continuously removed.

The devices, systems, and methods described herein work particularlywell in lesions that are challenging to treat with other systems, i.e.,at bifurcations, in tortuous arteries, and in arteries which are subjectto biomechanical stresses, such as arteries in the periphery, e.g.,located within the knee or other joints (as will be described in greaterdetail later).

The devices, systems, and methods can also perform a wide variety ofother treatments, including biopsies, tumor removal, fibroid treatment,debulking of unwanted hyperplastic tissues such as enlarged prostatetissue, or other unwanted tissue such as herniated spinal disc material.Any of the devices, systems, and methods described herein may also beused as a tool to treat chronic total occlusions (CTO) or a completeblockage of the artery. The flexible, low profile catheter systemsdescribed herein allow for ease of access to the treatment site andminimizes trauma or collateral damage to surrounding healthy tissue.With a continuous aspiration capability, contamination of thesurrounding tissue during device introduction, treatment, and removal isreduced or even eliminated. In addition, aspiration can be used totransfer biopsy tissue samples to outside the body for testing with thecatheter remaining in situ. This helps the physician make real timedecisions in advancing treatment of malignant tissue.

A shield or housing on the cutter assembly 102 maintains controlledexcision of tissue by limiting the depth of cutter engagement andthereby prevents the physician from inadvertently cutting into healthysurrounding tissue. The tip steering capability of the system allows thephysician to direct the cutter 108 towards desired site of tissueremoval and minimizing collateral tissue damage. By deflecting thecutter and rotating the deflection to sweep in an arc, the catheter canexcise large plaque deposits, tumors, or tissue lumps larger than thediameter of the catheter. Thus, excision of large tumors can be achievedthrough a small access channel and thereby minimizing trauma to thepatient.

The devices, systems, and methods described herein can also debulkstenosis in arteriovenous (AV) hemodialysis access sites (fistulae andsynthetic grafts), as well as to remove thrombus. For example, byremoving the cutter housing and recessing the fluted cutter within thecatheter body, a suitable non-cutting thrombectomy catheter may beconstructed.

The devices, systems, and methods described herein can also be used forexcising bone, cartilage, connective tissue, or muscle during minimallyinvasive surgical procedures. For example, a catheter that includescutting and burr elements may be used to gain access to the spine forperforming laminectomy or facetectomy procedures to alleviate spinalstenosis. For this application, the catheter may be further designed todeploy through a rigid cannula over part of its length, or have a rigidportion itself, to aid in surgical insertion and navigation.

It is also possible to use the devices, systems, and methods describedherein to restore patency to arterial lesions in the coronarycirculation and in the cerebrovascular circulation, both by debulking denovo lesions and by debulking in-stent restenosis. FIG. 35 shows thesystem 100 removing lesions within a stent or coil.

II. Desirable Technical Features

The debulking system 100 can incorporate various technical features toenhance its usability, which will now be described.

A. The Cutter Assembly

1. Cylindrical Housing Cutter Assemblies

FIG. 2A illustrates an exploded view of an exemplary embodiment of afront cutting cutter assembly 102. In this variation, the cutterassembly 102 includes a cylindrical housing 104 having an opening 107located on its distal face adapted to allow a cutter 108 to extendbeyond the distal face. The cutter 108 may comprise one or more cuttingedges. In the illustrated embodiment, the cutting edges comprise a firstset of cutting edges 112 that extend along (or substantially along) thecutter 108 and a second cutting edge 109 that extends only along aportion of the cutter 108. Although the number of cutting edges canvary, typically the cutting edges will be symmetric about an axis 111 ofthe cutter 108.

FIG. 2B also shows a variation of the cutter 108 that comprises a distalportion 90 mounted on a proximal portion 92 (where the proximal cutterportion 92 can also be referred to as a cutter core adapter 92). Theproximal cutter portion 92 contains a shaft 94 terminating in a matingpiece 140, with the mating piece 140 nested within an opening in thefront face of the distal cutter 90. The cutter assembly 102 can alsoinclude a guidewire lumen 130 to allow for passing of a guidewirethrough the cutter assembly 102 and device 100.

The cutter 108, as described herein, is preferably made of hard,wear-resistant material such as hardened tool or stainless steels,Tungsten carbide, cobalt chromium, or titanium alloys with or withoutwear resistant coatings, such as Titanium Nitride. However, any materialcommonly used for similar surgical applications may be employed for thecutter. The outer surfaces of the proximal end of the cutter 108 aretypically blunt and are designed to bear against the housing 104.Typically, these surfaces may be parallel to the inner surface of thehousing 104.

FIGS. 3A to 3E illustrate additional variations of the cutter assembly102. In such a variation, the front edge of the housing 104 can functionas a front or forward cutting surface 113. In one variation, the cutter108 may be tapered or rounded such that the front of the cuttercomprises a rounded or partial-ball shape. As shown, the front cuttingsurface 113 can be beveled on an outside surface of the housing 104.Such a beveled feature reduces the risk of the cutting surface 113 fromgouging or otherwise damaging the wall of a vessel. As noted above, theforward cutting surface 113 engages and removes tissue or plaque 4 whenthe device is advanced in a distal direction within a body lumen 2 asshown in FIG. 3F. As discussed herein, features of the device 100include a guidewire 128 to assist in preventing the device fromexcessively cutting the lumen wall 2.

The housing 104 can either be configured to rotate with the cutter 108or can be stationary and function as a scraping, scooping, or chiseltype surface. For example, FIGS. 3A and 3B show a variation where thehousing 104 can be affixed to the cutter 108 allowing for rotation ofthe entire cutting assembly 102 about the catheter body 120. The systemmay also include a ferrule 116 that permits coupling of the catheterbody 120 to the cutter assembly 102. The ferrule 116 may serve as abearing surface for rotation of the cutter 108 within the cutterassembly 102. In the illustrated example, the cutting assembly 102includes adjoining recessed pin cavities 103 for securing the housing104 to the cutter 108. FIG. 3B shows a cross sectional view of thecutter assembly 102 of FIG. 3A. As illustrated, in this particularvariation, the entire cutting assembly 102 rotates relative to theferrule 116 which provides a bearing surface for the rotational housing104. The proximal portion 92 of the cutter 108 rotates within theferrule while the proximal end of the housing 104 rotates about theferrule 116.

The housing 104 can be linked to the cutter 108 in a variety of ways asis well understood by those skilled in the art. For example the housing104 can be directly linked or affixed to the cutter 108 via connectionpoints 103 so that both rotate together. Alternatively, the housing 104can be geared to rotate faster or slower than the cutter 108. In yetanother variation, the gearing can be chosen to permit the housing 104to rotate in an opposite direction than the cutter 108.

Variations of the cutting assemblies include cutters 108 that protrudepartially from the forward cutting surface 113 of the housing 104. Inother variations, the cutter 108 can extend further from the housing 104or the assemblies can comprise cutters 108 that are totally recessedwithin the housing 104. In certain variations, it was identified thataligning the cutting surface 113 of the housing 104 with the deepestpart of a flute 110 on the cutter 108 allows for improved clearing ofdebris, especially where a single or double fluted cutting edgeconfiguration is used on a distal portion of the cutter 108.

In any case, the fluted cutting edge 112 impels tissue debris back intothe catheter. The outer surface of the housing, proximal to the forwardcutting surface 113 can be smooth to protect the lumen wall from thecutting action of the cutting edges. When the cutting assembly 102 isdeflected, the outer surface of the housing 104 becomes flush againstthe lumen wall and prevents the cutting edges from engaging the vesselwall. As the cutter assembly is advanced forward, it removes plaque 4protruding from the lumen 2 wall and tissue debris is impelled backwardsby the fluted edge 112 of the cutter 108.

FIG. 3C illustrates an additional variation of a cutting assembly 102where a housing 104 of the cutting assembly 102 remains stationary abouta catheter body 120 or ferrule 116 while the cutter 108 rotates withinthe ferrule. In this embodiment, the inner portion of the ferrule 116may provide a bearing surface for the proximal end 92 of the cutter 108.The housing 104 may be affixed to the ferrule 116 and may also functionas a bearing surface for the rotating cutter 108.

The cutter 108 rotates relative to the housing 104 such that, thecutting surface 112 on the cutter 108 shears or cleaves tissue and trapsthe tissue inside the housing 104 so that it can be evacuated in aproximal direction using the impeller action of the helical flutes 110and vacuum from the torque shaft 114 and/or conveying member 118.

FIG. 3E shows an exploded view of the cutting assembly of FIG. 3C.Again, the cutter 108 can include a distal cutting portion 90 and aproximal cutting portion 92. The illustrated configuration provides adevice having fewer cutting edges 112 on a distal portion 90 of thecutter and increased cutting edges 109 and 112 on a proximal cuttingportion 92. However, variations include a traditional fluted cutter aswell. The housing 104 is mounted about the cutter portions 90 and 92 andoptionally secured to either the catheter body 120 or ferrule 116. Asnoted above, the housing 104 can also be affixed to the cutter so thatit rotates with the cutter.

In alternate variations, the mating surface 140 of the cutter assembly102 can function as a blunt bumper at the very tip of the cutter 108that acts as a buffer to prevent accidental cutting into the guidewireor the vessel wall given the cutter assemblies' open distal design. Inadditional variations, the housing 104 could be expandable (such as abasket or mesh). As the cutter 108 gyrates inside the housing, thehousing may be adapted to expand to cut a larger diameter.

FIG. 3F illustrates a cutting assembly 102 having a forward cuttingsurface 113 at a distal opening 117 of a housing 104. The housing 104rotates along with the cutter 108 to assist in removal of tissue. Asnoted above, the forward cutting surface 113 engages and removes tissueor plaque 4 when the device is advanced in a distal direction within abody lumen 2. As discussed below, features of the device, including aguidewire 128 assist in preventing the device from excessively cuttingthe lumen wall 2.

FIGS. 4A and 4B show a cutter assembly 102 adapted for forward cutting.This embodiment includes an open ended housing 104 where the cutterextends distally from the housing. However, a blunt bumper 119 at thedistal tip of the cutter 108 acts as a buffer to prevent accidentalcutting into the guidewire 128 or excessively into the lumen wall 2. Inaddition, this embodiment can optionally incorporate an additionalhousing portion 121 on a back end of the cutter assembly 102 thatpartially shields the cutter 108 from deep side cuts into the lumen wall2.

Referring to FIG. 2A, a torque shaft 114 rotates inside the outercatheter body 120, sweep frame 250 and ferrule 116 to rotate the cutterand pull or aspirate tissue debris in a proximal direction. Theclearance between the catheter body 120 and conveying member 118, aswell as the pitch and thread depth of the conveying member 118, may bechosen to provide the desired pumping effectiveness, as will bedescribed in greater detail later.

As seen in FIG. 2A, the ferrule 116 can have a distal bearing surface tobear against the proximal surface of the cutter 108 and keeps the cutteraxially stable in the housing 104. In cases where the housing isstationary, the ferrule 116 can be rigidly bonded/linked to the housing104 using solder, brazing, welding, adhesives (epoxy), swaging, crimped,press-fit, screwed on, snap-locked or otherwise affixed. As shown, theferrule 116 can have holes or other rough features that allow forjoining with the catheter body 120. While adhesives and heat fusing maybe employed in the construction, such features are not required. Oftenadhesives are unreliable for a small surface contact and heat fusing cancause the catheter body 120 to degrade.

The use of a mechanical locking ring 126 allows the cutting assembly 102to be short. Such a feature is important for maximizing the flexibilityof the distal section 122 of the catheter 120 as it is required tonavigate tortuousity in blood vessels. In one variation, a ring or band126 can be swaged onto the catheter body 120 and over the ferrule 116.This drives portions of the ring/band as well as the catheter body intothe openings of the ferrule 116 allowing for increased strength betweenthe cutter assembly 102 and catheter body 120.

FIGS. 5A and 5B show a respective perspective view and cross-sectionalside view of another variation of an open ended cutter housing 104. Asshown, the cutter housing 104 includes an opening 107 located on a frontface of a cylindrical housing 104. In this variation, the front edge 113of the housing 104 can function as a front or forward cutting surfaceand has a beveled surface 177 on an inside surface of the housing 104.Such a beveled feature reduces the risk of the cutting surface 113 fromdriving into the wall of a vessel. As shown, some variations of thecutter housing 104 include a bearing surface 178 located within thehousing 104. In an additional variation, to control the degree to whichthe cutting assembly 102 removes tissue, the distal end or cuttingsurface 177 of the housing 104 can be scalloped or serrated. Forexample, instead of being uniform, the cutting surface 177 can varyalong a circumference of the housing in an axial direction (e.g., theserrated edges of the cutter extend along an axial length of thehousing).

Additional variations of an open ended cutter assembly 102 comprise aspinning turbine-like coring cutter 172 is shown in FIGS. 6A and 6B.FIG. 6B shows a side view of the coring cutter 102. In use, the coringcutter can be hydraulically pushed to drive the sharp edge throughtissue. The turbine like cutters 172 have helical blades 174 on theinside of the sharp cylinder housing 176.

An element of the coring cutter 102 may also have spokes or centeringdevices 184 as shown in FIGS. 7A to 7F to center the housing 104 aboutthe guidewire. Optionally, the centering devices 184 may comprise anelement of the guidewire 128, as shown. This helps to keep the cut ofthe plague centered about the vessel wall for safety. The spokes 184also act as an impeller to pull stenotic tissue back and this helps todrive the cutter forward as well as achieve aspiration to minimizeembolization.

2. Guarded Housing Cutter Assemblies

a. Cutting Edge Configurations

FIG. 8A shows a variation of a tissue removal or debulking system 100where the cutter assembly 102 is within a guarded housing 104. In thisvariation, the cutter assembly contains a first set of cutting edges 112and a second set of cutting edges 109, where the first cutting edges 112may extend along the entire length of the cutting assembly 102 (i.e.,the entire length that is exposed in the openings 106 of the housing104). In contrast, the second set of cutting edges 109 (in the figureonly one such second cutting edge is visible) extend only along aportion. However, variations of the devices, systems, and methodsdescribed herein can include any number of cotter configurations asdescribed herein or as known by those skilled in the art. Furthermore,although the illustrated system 100 shows a plurality of openings 106 inthe housing 104, alternative cutting assemblies 102 can include ahousing having a single opening on a distal face, as previouslydescribed.

FIG. 8B shows a variation of the cutting edges comprising a first set ofcutting edges 112 that extend along (or substantially along) the cutter108 and a second cutting edge 109 that extends only along a portion ofthe cutter 108. Although the number of cutting edges can vary, typicallythe cutting edges will be symmetric about an axis 111 of the cutter 108.For example, in one variation, the illustrated cutter 108 will have apair of second cutting edges 109 symmetrically located about the cutter108 and a pair of first cutting edges 112 symmetrically located aboutthe axis 111 of the cutter 108. Accordingly, such a construction resultsin two cutting edges 112 located on a distal portion of the cutter 108and four cutting edges 109 and 112 located on a proximal portion of thecutter 108.

Providing a cutter 108 with fewer cutting edges on a distal cuttingportion and an increased number of cutting edges on a proximal cuttingportion allows for a more aggressive cutting device. As shown, thecutter 108 can be configured with cutting edges 109, 112 that areadjacent to grooves, channels, or flutes 110 (where the combination isreferred to as a “cutting flute”). The cutting flute 110 provides a pathfor the cut material to egress from the treatment site through thesystem 100, and improves the impelling force generated by the cutter108. The helical flutes 110 and sharp cutting edges 112 may be parallelto each other and may be wound from proximal to distal in the same senseas the rotation of the cutter. When the cutter 108 rotates, it becomesan impeller causing tissue debris to move proximally for evacuation.

By reducing the number of flutes on the distal portion of the cutter,the flutes can be made deeper. The deeper flutes allow the cutting edgeadjacent to the flute to remove greater amounts of material. However,increasing the size of the material can also increase the chances thatthe material becomes stuck or moves slowly through the catheter 120during removal. To alleviate this potential problem and increase theefficiency of transporting the material through the catheter, the cuttercan be configured with an increased number of cutting edges towards arear of the cutter that reduce the size of the cut material by providinga second cut of the material to further reduce the material size forimproved transportation.

By controlling the number of cutting edges 109, 112 that are exposedthrough openings 106 in the housing 104, it is possible to control therelative amount of cutting engagement (both length of cutting and depthof cut, together which control the volume of material removed per unitrotation of the cutter). These features allow independent control of themaximum torque load imposed on the system 100. By carefully selectingthe geometry of the flutes and or cutting edges 112 relative to theopenings 106 in the housing 104, it is possible to further control thebalance of torque. For example, the torque load imposed on the system iscaused by the shearing of tissue when the cutter edge 112 and/or 109 isexposed by passing through the housing window 106. If all cutter edgessimultaneously shear, as for example when the number of housing windowsis an even multiple of cutter edges, the torque varies cyclically withrotation of the cutter. By adjusting the number of cutters and windowsso one is not an even multiple of the other (for example, by using fivewindows 106 on the housing and four cutting edges on the cutter 108), itis possible to have a more uniform torque (tissue removal from shearingaction) during each rotational cycle of the cutter 108. It is to beappreciated that the cutting edge configurations described above areavailable for all cutter assembly embodiments described herein.

The geometry of the cutter 108 and housing 104 can be used to tailor thedesired degree of cutting. The housing 104 and orientation of theopenings 106 can be used to limit the depth of cutting by the cutter108. In addition, the distal end of the housing 104 may be domed shapedwhile the proximal end may have a cylindrical or other shape. Forexample, by creating larger apertures or windows 106 in the housing, alarger portion of cutter 108 may be exposed and the rate of cuttingincreased (for a given rotation speed). By placing the cutting window106 on a convex portion or side wall 105 of the housing 104, thedebulking effectiveness is much less sensitive to the alignment of thecutter housing 104 to the lesion, than if the window 106 were on thecylindrical portion of the housing. This is a key performance limitationof traditional directional atherectomy catheters. In addition, placementof the window 106 on the convex portion of the housing creates a secanteffect (as described below).

b. Cutter Assembly Configurations

FIG. 9 illustrates an exploded view of a cutter assembly 102 and ferrule116. In this variation, the cutter assembly 102 includes a housing 104having three openings 106 symmetrically placed about a sidewall 105 ofthe housing. FIG. 9 also shows an embodiment of cutter 108 thatcomprises a distal portion 90 mounted on a proximal portion 92 (wherethe proximal cutter portion 92 can also be referred to as a cutter coreadapter). The proximal cutter portion 92 contains a shaft 94 terminatingin a mating piece 140 for coupling the cutter 108 to the housing 104(where the mating piece 140 nests within a center lumen 142 in a frontface of the housing 104. The cutter 108 can also include a passage 130for passing of a guidewire through the system 100.

Although the inventive system 100 includes embodiments of cutters formedfrom in a unitary body, providing the cutter 108 with distal andproximal 90, 92 cutter portions allows for optimal selection ofmaterials. In addition, as shown, a first cutting edge 112 can extendalong both cutter portions 90, 92 while a secondary cutting edge 109 mayextend only along the proximal cutter portion 92. Given thisconfiguration, when the cutter portions 90, 92 join to form the cutter108, the distal portion 90 of the cutter only contains two flutedcutting edges while the proximal cutting portion 92 includes four flutedcutting edges. Naturally, any number of fluted cutting portions arewithin the scope of the invention. However, variations include fewercutting edges on a distal end of the cutter 108 relative to the numberof cutting edges on a proximal end of the cutter 108. Moreover, thecutting edges may or may not be symmetrically located about the cutter.

FIG. 10 shows the housing 104 having a distal nose with the center lumen142 for receiving the mating piece 140 of the cutter 108. Such featuresassist in centering the cutter 104 concentrically inside the housing104. As described below, variations of the cutter assembly 102 includethe addition of a burr element for grinding hard tissue such ascalcified plaque of a dilator member for separating materials towardsthe openings 106.

FIGS. 11A through 15 show various additional examples of cuttingassemblies 102 including a guarded housing 104, and that can beincorporated with the system 100.

FIG. 11A illustrates the cutting assembly shown in FIGS. 8A, 8B, and 9where the openings 106 form helical slots in the housing 104. Theopenings 106 may or may not be aligned with the cutting edges 109, 112of the cutter 108. For aggressive cutting, the slots 106 and cuttingedges 109, 112 can be aligned to maximize exposure of the tissue tocutting edges. In other words, the cutting edges 109, 112 and openings106 can be in alignment so all cutting edges 109, 112 are exposed at thesame time to allow simultaneous cutting. Alternatively, alignment of theopenings and edges 109, 112 may be configured so that fewer than all thecutting edges 109, 112 are exposed at the same time. For example, thealignment may be such that when one cutting edge is exposed by anopening 106, the remaining cutting edges are shielded within the housing104. Variations of such a configuration allow for any number of cuttingedges to be exposed at any given time. In addition, the variationdepicted in FIG. 11A shows a window or opening 106 large enough toexpose both the first 112 and second 109 cutting edges. However, inalternate variations, the windows can be configured to only expose thecutting edges 112 on the distal end of the cutter 108.

In another variation adapted to even out the torque profile of thedevice when cutting, the cutter 108 can be configured such that thenumber edges/cutting surfaces 109, 112 of the flutes 110 that arealigned with the housing openings 106 does not vary throughout therotational cycle. This prevents the catheter from being overloaded withtorque spikes and cyclic torque variations due to multiple cuttingedges/flutes engaging with tissue in synchrony. In other words, thelength of the cutting surface 112 exposed through the openings 106 ofthe housing 104 remains the same or constant.

In the variation shown in FIG. 11B, the cutting edges 109, 112 areconfigured to capture debris within the flute 110 as the cutter 108rotates. Typically, the cutter 108 may be designed with a secant effect.This effect allows for a positive tissue engagement by the cutter 108.As the cutter 108 rotates through the opening, the cutting edge movesthrough an arc where at the peak of the arc the cutting edge protrudesslightly above a plane of the opening 106. The amount of positive tissueengagement can be controlled through selection of the protrusiondistance through appropriate design of the housing geometry (forexample, by a combination of location and size of the window 106 andradius of curvature of the housing 104). The cutting edge 109 or 112 canextend out of the housing 104 through the window 106 as it rotates. Thisstructure can also be designed to drive or impel the debris to theconveying member 118 (see FIG. 2A). In this case, the flutes 110 withinthe cutter 108 are helically slotted to remain in fluid communicationwith the conveying member 118.

FIGS. 11A and 11B also show a surface of the cutter 108 having acurved-in profile distally and is close to the housing 104 surface. Notethat housing openings 106 with this curved profile allows the cuttingedge 112 to protrude beyond the housing's outer surface. In other words,the openings 106 form a secant on the curved surface of the housing 104.Such a feature allows improved cutting of harder/stiffer material likecalcified or stiff fibrous tissue where such tissue does not protrudeinto the housing 104.

As shown in FIG. 11C, variations of the cutter 108 may have cuttingedges 109, 112 with positive rake angles α—i.e., the cutting edge ispointed in the same direction as that of the cutter rotation. Thisconfiguration maximizes the effectiveness of the impelling and cuttingaction (by biting into tissue and avoiding tissue deflection).

FIG. 12 shows a variation of a cutter assembly 102 where a housing 104of the cutter assembly 102 includes m conical, tapered, or dilatorextension 133 extending from a front face of the housing 104. Thedilator extension 133 is adapted to serve a number of purposes, namelythat it can help prevent the cutting assembly 102 from damaging a vesselwall. In addition, the added structural reinforcement of the front faceof the housing 104 reduces the chance that the rotating cutter 108actually cuts through the housing 104 if the struts were to deflectinward. However, one important feature of the dilator extension 133 isthat it provides a tapered surface from a guidewire to the openings 106in the housing 104. Accordingly, as the dilator extension 133 advancesthrough occlusive material, the dilator extension 133 forces or dilatesmaterial away from a guidewire towards the openings 106 and cuttingedges. In order to dilate material away from a center of the cutterassembly 102, the dilator extension 133 must have sufficient radialstrength. In one example, the dilator extension 133 and housing 104 canbe fabricated from a single piece of material as discussed herein.

The dilator extension 133 typically includes an opening 130 for passageof a guidewire. In addition, in most variations, a front end 135 of thedilator extension 133 will be rounded to assist in moving the occlusivematerial over a surface of the dilator 133. Furthermore, the surface ofthe dilator extension 133 can be smooth to permit sweeping of thecutting assembly 102 as discussed below. Alternatively, the dilatorextension 133 can have a number of longitudinal grooves to directmaterial into the openings 106. In additional variations, the dilatorextension 133 may not include an opening 130. In such a case, thedilator extension 133 may fully taper to a closed tip.

FIGS. 13A to 13C show use of a system 100 incorporating a dilatingmember 133. In this variation, the device 100 is advanced over aguidewire 128. However, use of a guidewire 128 is optional. As thedevice 100 approaches the plague or occlusive material 4, the dilatingmember 133 forces the plaque 4 away from a center of the system 100 andtowards openings 106 in the cutting assembly 102 as shown in FIG. 13B.Clearly, the dilating member 133 must have sufficiently radial strengthso that it forces the obstruction towards the openings 106. However, inthose variations where the dilating member 133 is conical or tapered,the plaque material 4 is gradually moved towards the openings 106. Inthose devices not having a dilating member 133, the physician must applyexcessive force to move the cutter against the plaque 4. In someexcessive cases not incorporating a dilating member 133, the cutter maybe able to shear through a cutter housing leading to failure of thedevice.

FIG. 13C illustrates a situation where the system 100 traverses theentire occlusion 4. However, as described in detail later, the devicemay be configured for sweeping within the vessel. As such, the physicianmay choose to sweep the system 100 within the occlusion to open theocclusion during traversal of the occlusion or after a path is createdthrough the occlusion. In either case, the nature of the dilation member133 also functions to keep the cutting assembly 102 spaced apart from awall of the vessel 2.

FIGS. 14A and 14B show another variation of a cutter assembly 102 havinga forward cutting surface 113 on a distal portion of the cutter 108. Inthis variation, the cutter housing 104 may include two or more largeopenings 106 that allow the forward cutting surface 113 to engage tissuewhen moved in a distal direction. The cutter 108 may also include aplurality of fluted cutting edges 112.

As shown in FIG. 15, a cutter assembly 102 can also have a burr 180protruding from its distal portion. Although the burr 180 may have anytype of abrasive surface, in one variation, this burr 180 is blunt andhas fine grit (such as diamond grit) to allow for grinding of heavilycalcified tissue without injuring adjacent soft tissue. This combinationof a burr 180 and cutter 108 allow the cutter assembly 102 to removehard stenotic tissue (e.g., calcified plaque) using the burr 180 whilethe sharp-edged shaving cutter 108 removes softer tissue such asfibrous, fatty tissue, smooth muscle proliferation, or thrombus. Invariations, the burr 180 can also have helical flutes to help withaspiration, or the burr can be incorporated into a portion of thecutting edge (for example, the most distal aspect of the cutter 108).

c. Distal and Proximal Cutting

FIGS. 16A and 16B show an additional variation of a cutting assembly 102adapted for use with the system 100. FIG. 16B shows a side view of thecutter assembly 102 of FIG. 16A. In this embodiment, the cuttingassembly 102 includes larger windows 106 to accommodate a cutter 108that includes a plurality of directional cutting surfaces 112, 113, and115. As the cutter 108 rotates within the housing 104, the flutedcutting edge 112 cuts in a direction that is tangential to a rotationaldirection of the cutter 108. In other words, the fluted cutting edges112 cut material that is about the perimeter of the cutter 108 as itspins. The cutter 108 also includes on or more forward and rearwardcutting surfaces 113, 115. These cutting surfaces 113, 115 engage tissuewhen the catheter is run in a forward direction or rearward direction.The ability to engage and remove tissue in multiple directions have beenshown to be important for effective debulking. However, a variation of acutter 108 in the present invention can include a cutter 108 with one oftwo directional cutting surfaces. For example, the fluted cutting edges112 can be combined with either the forward 113 or rearward 115 cuttingsurfaces. The ability to debulk in a forward, rearward, and rotationaldirections also reduces the chance that the cutter assembly deflectsfrom stubborn or hard tissue.

B. The Catheter Assembly

1. Catheter Body

FIG. 17 shows the distal portion 122 of the atherectomy system 100having a cutter assembly 102 extending from the catheter body 120. Aswill be discussed below, the catheter body 120 can be coupled to arotating mechanism or motor 150, desirably in the handle 200, whichultimately drives the cutter assembly 102 via a torque shaft 114.

In general, for proper debulking of tissue within vessels, the system100 desirably includes a catheter 120 that is able to support the cutterassembly 102 with sufficient apposition force (bending stiffness). Thecatheter body 120 should be torqueable enough (i.e., have sufficienttorsional stiffness) so that the physician can point the cutter assembly102 to the desired angular position within the vessel 2. The system 100should also be pushable enough (i.e., have sufficient column stiffness)to allow proper cutting as the physician advances the device throughtissue. However, these needs must be balanced against making a devicethat is too stiff to reliably access tortuous or angled anatomy. Inorder to balance these requirements, a variation of the system 100 canhave a more flexible distal tip location 122 (e.g., within the last 10cm as a non-limiting example) to improve the navigation (includingtrackability over a guidewire, for example) in tortuous anatomy. Becausethe overall stiffness (in compression and torque) depends upon the fulllength of the catheter 120, but navigation is influenced mainly by thedistal tip region 122, this method is one way to optimize severalvariables at the same time.

An additional design for increased torque and push is to construct thecatheter body 120 and/or sweep member 270 (to be discussed in greaterdetail below) from a braid over a wound coil, with an optional polymericjacket covering. This composite construction may be over a polymer linermade of a material such as PTFE. Yet another variation includes acatheter body 120 and/or sweep member fabricated from a metal tubehaving selective cuts along the length of the tube (e.g., stainlesssteel or nitinol) to create the desired profile of stiffness (bending,torsion, and compression) along the length of the catheter 120. Thisslotted metal tube can be lined or jacketed with polymeric material, andfurther may be treated to produce hydrophilic, hydrophobic, or drugbinding (heparin, antimicrobial) properties. The configurationsdescribed herein apply to any debulking device described herein.

The catheter body 120 may also be composed of a reinforced sheath, suchas a metal braid sandwiched in a polymeric matrix of such materials ashigh density polyethylene (HDPE), polyethylene (PE), fluoro-polymer(PTFE), nylon, polyether-block amide (PEBAX), polyurethane, and/orsilicone. The sheath is stiffer proximally than distally. This can beachieved by using softer grades of polymers distally and/or having nometal braid distally.

FIGS. 18A through 18F illustrate possible variations of a compositeconstruction that can be employed in fabricating either a catheter body120 and/or a sweep member 270 for use in the debulking systems describedherein. FIG. 18A shows a composite construction 290 of a slotted tube292, where the tube can be selected from e.g., a polymer, a metal—suchas stainless steel, or a shape memory alloy—such as a super-elasticNitinol tube, or a combination therein. The pattern of slots along thetube 292 can be tailored to achieve the desired properties such asgraded stiffness along the long axis and/or the short axis of thecatheter body 120. The construction 290 can optionally include polymericcoatings, sleeves, or liners 298 in the inner and/or outer surfaces ofthe tube 292.

FIG. 18A also shows a tube 292 as having a first region 294 and a secondregion 296 where the frequency of the slots varies between regions. Anynumber of slotted tube configurations, such as those found in medicaldevices designed for navigation to tortuous areas, can be employed inthe designs herein. Such designs, when combined in atherectomy—debulkingcatheters with sweep frames as described herein, provide significant andunexpected improvements in steering and cutting of lesions.

FIG. 18B illustrates another variation of a composite construction 300that can be employed in a catheter body 120 and/or a sweep member 270for use with variations of the debulking systems 100 described herein.As illustrated, the construction 300 includes a coil member 302 coveredby a braid 304. The coil and braid can each be fabricated from anymaterial commonly known in the field of braided/coiled catheters. Forexample, the coil 302 can be wound from a super-elastic wire or ribbon.While the braid can comprise a plurality of super elastic or stainlesssteel filaments braided or woven together. FIG. 18B also shows the braid304 covered by a polymeric coating, sleeve, or liner 306.

In an additional variation, the catheter body 120 and/or sweep member270 can comprise a spiral cut tube covered by a liner or polymericlayer. In such a case, the angle of the spiral as well as the width canbe selected to impart desired characteristics on the device. Forexample, the spiral can be selected to maximize pushability of thedevice while maintaining a near one-to-one relationship between thecutting assembly 102 and proximal end of the device when rotating orsweeping the cutting assembly.

FIG. 18C shows yet another variation of a catheter body 120 and/or asweep member 270 for use with variations of the debulking systems 100described herein. As can be seen, the catheter body 120 may include amulti-body design having minimal torsional losses while maximizingbending in a first portion 120A and longitudinal stiffness in a secondportion 120B. The first portion 120A is shown having a dovetailconstruction adapted for predefined expansion between the dovetailfeatures, providing for controlled flexibility. The second portion 120Bis shown having a helical cut pattern creating a line-to-line fit ofsupports, which creates a helical series of uninterrupted material tomaintain bending-free transmission of torsional tensile and compressiveloads. This embodiment may also include an elastic outer or inner sheathor jacket 125 adapted to elastically constrain the dovetailed componentsfrom axially expanding, but allowing the distal portion 120A to radiallyflex.

FIGS. 18D and 18E show detailed views of embodiments of the first andsecond portions 120A and 120B, showing optional configurations of adovetail feature, with FIG. 18D showing a traditional dovetailconstruction, and FIG. 18E showing a serpentine configuration. It is tobe appreciated that other configurations are also possible. FIG. 18Fshows the catheter body 120 in a radially flexed position, showing thebending of the first portion 120A through the arced expansion of thedovetailed configuration.

Coatings can be applied to the moving components in the catheter 120 toreduce friction. In one embodiment, the catheter 120 and the torqueshaft 114 are coated with a hydrophilic coating (polyvinyl alcohol) toreduce friction between the moving components in the catheter 120. Thecoatings can also be hydrophobic (e.g. parylene, PTFE). The coatings canbe impregnated with heparin to reduce blood clotting on surface duringuse.

2. Torque Shaft and Conveyer Member

FIG. 19A illustrates a partial cross-sectional view of a variation ofthe distal portion 122 of the system 100 showing the placement of thetorque shaft 114 within the catheter body 120 and sweep frame 250. Asshown, this variation of the system 100 includes a conveyor member 118located within the catheter body 120 and on an exterior surface of thetorque shaft 114. The conveyor member 118 may be an auger type system oran Archimedes-type screw that conveys the debris and material generatedduring the procedure away from the operative site. In any case, theconveying member 118 may have a raised surface or blade that drivesmaterials in a proximal direction away from the operative site (see FIG.19B). Such materials may be conveyed to a receptacle outside of the bodyor such materials may be stored within the system 100. The torque shaft114 and conveying member 118 may extend along the full length of thecatheter and possibly into the handle 200, or the conveying member mayextend only along a portion of the length of the catheter 120. As shown,the torque shaft 114 and conveyor 118 fit within the sweep frame 250. Insome variations of the system 100, a cover or film can be placed betweenthe sweep frame 250 and torque shaft 114 to prevent debris from becomingtrapped within the serrations, slots or openings 252 of the sweep frame250. The cover or film may also act as a smooth, low friction surface.

FIG. 19C shows a partial sectional view of an alternative example of atorque shaft 114 for coupling to a cutter assembly 102. To aid inremoval of materials, the torque shaft 114 may be a set of counter-woundcoils, with the outer coil wound at the proper (greater) pitch to formthe conveying member 118. Winding the coils counter to each otherautomatically reinforces the torque shaft 114 during rotation.Alternatively, the torque shaft 114 may be made out of a rigid materialsuch as plastic, rendered flexible by incorporation of a spiral reliefor groove which acts as a conveying member 118. Although the shaft 114may be fabricated from any standard material, variations of the torqueshaft may include a metal braid and/or one or more metal coils embeddedin a polymer, such as PEBAX, polyurethane, polyethylene, fluoropolymers,parylene, polyimide, PEEK, and PET, as non-limiting examples. Theseconstructions maximize torsional strength and stiffness, as well ascolumn strength for “pushability”, and minimize bending stiffness forflexibility. Such features are important for navigation of the catheterthrough tortuous vessels but allow for smooth transmission of torqueover the long length of the catheter.

In the multi-coil construction, the inner coil should be wound in thesame sense as that of the rotation so that it would tend to open upunder torque resistance. This ensures that the guidewire lumen 130remain patent during rotation. The outer coil (conveying member) 118should be wound opposite the inner to counter the expansion to keep theinner coil from binding up against the catheter tube 120.

Typically the guidewire lumen 130 will be used to deliver a guidewire.In such cases, the central lumen 130 may be coated with a lubriciousmaterial (such as a hydrophilic coating or Parylene, for example) ormade of a lubricious material such as PTFE to avoid binding with theguidewire. However, in some variations, a guidewire section is affixedto the outer distal portion 122 of the catheter body 120, or to thecutter assembly housing 104 (i.e., rapid exchange, to be describedlater). Moreover, the central lumen 130 of the torque shaft 114 may alsobe used to deliver fluids to the operative site simultaneously with theguidewire or in place of the guidewire.

In some variations, the conveying member 118 may be integral to theshaft 114 (such as by cutting the conveying member 118 into the torqueshaft 114 or by extruding the torque shaft 114 directly with a helicalgroove or protrusion. In an additional variation as shown in FIG. 19D,an additional conveying member 118′ may be incorporated on an inside ofthe torque shaft 114, where the internal conveying member 118′ is woundopposite to that of the external conveying member 118. Such aconfiguration allows for aspiration and debris (via the externalconveying member 118) and infusion (via the internal conveying member118′), or vise-versa. Such a dual action can enhance the ability toexcise and aspirate plague by: (1) thinning the blood, whether byviscosity alone or with the addition of anti-coagulants such as heparinor warfarin (cumadin), and/or anti-platetlet drugs such as Clopidogrel,(2) improving the pumpability (aspirability) of the excised plaque byconverting it into a solid-liquid slurry that exhibits greater pumpingefficiency, and/or (3) establishing a flow-controlled secondary methodof trapping emboli that are not sheared directly into the housing, byestablishing a local recirculation zone.

As noted above, the conveying member 118 can be wound in the samedirectional sense as the cutter 108 and in the same direction ofrotation to effect aspiration of tissue debris. The impeller action ofthe cutter 108 moves the tissue debris from inside the housing 104opening (s) 106, 107, past the cutting edge(s) 112 and 109 to furthergrind the debris, and into the torque shaft 114. The pitch of thecutting edges 112 may be matched to that of the conveying member 118 tofurther optimize aspiration. Alternatively, the pitch of the conveyingmember 118 may be changed to increase the speed at which material movesonce it enters the conveying member 118. As discussed herein, debris canbe evacuated outside the body by the conveying member 118 action along aportion or the full length of the catheter body 120 and with or withoutsupplement of a vacuum pump 152 connected to the catheter handle 200.Alternatively, the debris may be accumulated in a reservoir within orattached to the system 100.

It may be advantageous to rotatably couple the torque shaft 114 to adrive unit 150 electromagnetically, without physical contact. Forexample, the torque shaft 114 can have magnetic poles installed at theproximal end, within a tubular structure that is attached to a sheatharound the torque shaft. The stationary portion of the motor 150 can bebuilt into the handle 200 that surrounds the tubular structure. Thiswould allow the continuous aspiration through the catheter body 120without the use of high speed rotating seals.

3. Sweep Frame

FIGS. 20A through 20C further illustrates one embodiment of a sweepframe 250 located within the catheter body 120. The sweep frame 250 maybe adapted to permit an axial length L of the distal portion 122 of thecatheter 120 to bend or articulate in response to a force typicallyapplied at a proximal portion of the catheter or at the handle 200 ofthe system 100. The applied force may be provided in a variety ofmanners, such as distally directed, proximally directed, and/orrotational, or any combination.

In the illustrated embodiment, the sweep frame 250 comprises a tubestructure having a plurality of serrations, slots, orsemi-circumferential openings 252. Overall, the area having the openings252 on the sweep frame 250 weaken the frame 250 by providing a sectionof reduced column strength on a first radial side 254 of the sweep frame(i.e., the sides containing the openings). The portion 256 of the sweepframe 250 that is not weakened maintains a column strength that isgreater than that of the first radial side 254 of the sweep frame 250.This constructions permits deflection of the distal portion 122 of thesystem 100 when an axial force 264 is applied to the sweep frame 250driving it against a fixed section (e.g., the cutter assembly 102,and/or a portion of the catheter body 120). In an alternativeembodiment, an axial force may be applied to the catheter 120 or torqueshaft 114, for example, the force driving a fixed section (e.g., thecutter assembly 102) against the sweep frame 250 and causing deflectionof the distal portion. As shown in FIG. 20C, this axial force compressesthe sweep frame 250 causing the area with the weakened column strengthto compress (i.e., the sides of the sweep frame 250 adjacent to theopenings 252 move towards one another on the first radial side 254).This in turn causes the deflection of the spine or strengthened side 256in a direction towards the first radial side 254. Because the sweepframe 250 may be coupled to the catheter (e.g., it may be fully orpartially encapsulated within the catheter body 120), the deflection ofthe sweep frame 250 causes deflection 262 of the distal end 122 of thecatheter body 120 and cutter assembly 102 in a direction towards thefirst radial side 254 causing an axis of the cutter assembly 102 to forman angle A with an axis of the proximal portion 258 of the sweep frame250.

The sweep frame 250 is rotatable independently of the rotatable cutter108 and torque shaft 114. In certain variations, the sweep frame 250 isindependently rotatable from the catheter body 120 as well. In suchconfigurations, as the deflected sweep frame 250 rotates, the cuttingassembly and/or distal catheter portion 122 move in an arcuate pathrelative to an axis 260 of a proximal end 258 of the sweep frame 250.The sweep frame 250 can also be configured to rotate with the catheterbody 120. In this latter configuration, the cutter assembly 102 can alsorotate with the sweep frame 250 while the rotatable cutter 108 still isable to rotate independently of the sweep frame 250.

FIGS. 21A through 21C illustrate additional variations of sweep frames250 for use with the cutting assemblies 102 and catheters 120 describedherein. For purposes of highlighting the sweep frame 250, the torqueshaft 114 is omitted from FIGS. 21A to 21C. However, as shown in FIG. 17for example, a torque shaft 114 may extend through the sweep frame 250where the torque shaft and sweep frame can rotate independently from oneanother.

FIG. 21A shows a distal view of a debulking system 100 where thecatheter body 120 is partially removed to show a variation of a sweepframe 250. In this variation, the sweep frame 250 may be constructedfrom a laser cut tube having serrations, openings, or slots 252. Theopenings 252 create a weakened section along a first radial side 254 ofthe sweep frame 250. The side opposite 256 to the first radial side 254comprises an area of increased column strength. Accordingly, as aphysician applies an axial force (e.g., in a distal direction) at theproximal end of the system 100, typically via a sweep member 270, asdiscussed below, the axial force causes the sweep frame 250 to compressagainst a fixed area within the distal portion 122 of the catheter body120 (see FIG. 20B). As the force compresses the sweep frame 250, thesweep frame 250 is forced to compress at the weakened section along thefirst radial side 254 causing bending at the continuous area or spine256 of the sweep frame 250 in the direction indicated by the arrow 262(see FIG. 20C). The fixation area (the area against which the sweepframe 250 encounters resistance) can be the cutter assembly 102 or adistal area on the catheter body 120. However, any area will suffice solong as the sweep frame 250 is able to bend upon the application of aforce.

The spacing and size of the openings 252 can be selected to allow apre-determined bend upon deformation of the sweep frame 250. Forexample, the openings 252 can be selected to limit deflection of thedistal portion 122 of the catheter to plus or minus 90 degrees or to anyangular bend to provide an added safety measure when the system 100 isused within a vessel. Moreover, the spacing between adjacent openings252 and/or the size of openings can vary in the sweep frame 250. Forexample, the spacing and/or size of the openings 252 can increase ordecrease along the length of the sweep frame 250. In an additionalvariation, the spacing and the size of the openings can vary inverselyalong the length of the sweep frame 250.

In the illustrated variation, the size of the openings 252 in the sweepframe 250 may increase in a direction away from the first radial side254 of the sweep frame 250. This configuration was found to minimiseinterference with the torque shaft (not shown).

In addition, the sweep frames 250 described herein can have any numberof features to assist in joining the sweep frame 250 to the catheter120. For example, in those cases where the sweep frame 250 isconstructed from a super-elastic or shape memory alloy, the frame 250can include one or more openings 253 located in a sidewall to increasethe bond between the superelastic/shape memory alloy component and aregular metallic shaft.

4. Sweep Member

FIG. 20C illustrates the tissue debulking system 100 upon theapplication of force indicated in the direction of arrow 264. As notedabove, force 264 may be applied by the physician at the proximal end orhandle 200 of the system 100. In some variations, the force may beapplied through the use of a sweep member 270 that is axially moveablewithin the catheter body 120. The sweep member 270 can comprise atubular structure or a spline or wire that has sufficient columnstrength to compress as well as rotate the sweep frame 250. Because thedistal end of the sweep frame is prevented from moving distally(typically because the cutter assembly 102 is affixed to the catheterbody 120), the sweep frame bends at the spine 256 in the direction ofthe first radial side 254. As shown, the spacing between the openings252 may simply decrease starting at the first radial side 254 andextending to the spine 256. This causes articulation of the cuttingassembly 102 so that an axis 111 of the cutting assembly becomes offsetfrom an axis of the proximal end 258 of the sweep frame 250 as denotedby angle A. As noted herein, the angle A is not limited to that shown.Instead, the angle can be predetermined, depending on the constructionof a particular sweep frame 250 to provide any angle that is suited fora target vessel or body lumen, and may range plus or minus 90 degrees orto any predetermined angular bend.

In one variation, the sweep member 270 (also called a sweep shaft) maybe fabricated as a hypo-tube structure (constructed from a super-elasticalloy or a medical grade stainless steel, for example). The sweep member270 can have varying degrees of flexibility to allow the catheter 120 tobe more flexible at a distal portion and rigid at a proximal portion.This allows for improved navigation through tortuous anatomy as well asimproved transmission of torque generated at the proximal end of thedevice. In additional variations, the sweep-member 270 should not beprone to excessive compression or elongation given that it must transmitthe rotational force to the sweep frame 250.

Upon articulation of the cutting assembly 102, the physician can furtherrotate the sweep member 270 as shown by arrow 280. Rotation of the sweepmember 270 causes rotation of the sweep frame 250 when articulatedcausing movement of the cutting assembly 102 in an arc-type motion aboutan axis of the proximal end 258 of the sweep frame 250. This movementcauses the cutting assembly 102 having a flexible length L to movethrough an arc having a radius denoted by 282. In some variations of thedevice, the sweep frame 250 and sweep member 270 can rotateindependently of the catheter body 120. However, allowing the catheterbody 120 to rotate with the sweep frame 250 and sweep member 270 reducesthe resistance on the sweep member 270 as it rotates. In this lattercase, the catheter body 120, as well as the cutter housing 104, rotatewith the sweep frame 250. However, the rotatable cutter 108 (and thetorque shaft—not shown) still rotate independently of the sweep frame250.

Also as noted above, this ability to sweep the cutting assembly 102 inan arc or a circle larger than a diameter of the catheter 120 (or cutterassembly 102) allows the physician to create a significantly largeropening in the target site than the diameter of the cutting assembly 102itself. Such a feature eliminates the need to exchange the system 100for a separate cutting instrument having a larger cutting head. Not onlydoes such a feature save procedure time, but the system 100 is able tocreate variable sized openings in body lumens.

FIG. 20C also illustrates a variation of the sweep member 270 that canbe applied to any variation of the system 100 shown herein. In somecases it may be desirable to disengage the sweep member 270 from thesweep frame 250. In such a case, the sweep member 270 can be axiallyslidable to disengage the sweep frame 250. However, upon re-engagementwith the sweep frame 250, the sweep member 270 must also be able torotate the sweep frame 250. Accordingly, the sweep frame 250 and sweepmember 270 can include one or more keys and key-ways. Although theillustration shows the sweep frame 250 as having a keyway 266 at aproximal end 258 and the sweep member 270 as having a key 272, any typeof configuration that allows translation of rotation is within the scopeof this disclosure.

FIG. 21A illustrates a variation of a system 100 having sweep frame 250with a weakened section 268 having a varying column strength. In thisvariation, the column strength of the sweep frame 250 increases in acircumferential direction away from the first radial side 254. Theincrease in column strength prevents radial twisting of the sweep frame250 as it deflects. In the illustrated variation, the sweep frame 250comprises a plurality of reinforcement arms, ribs, or struts 274 withinthe openings 250 on the sweep frame 250 where the arms, ribs, or struts274 are configured to preferentially bend towards the spine 256 as thesweep frame 250 bends. In this variation, the portion containing thearms, ribs, or struts 274 that is adjacent to (but spaced from) thefirst radial side 254 comprises a second column strength that is greaterthan the column strength of the radial side but less than a columnstrength of the remaining spine 256. Again, the varying column strengthis intended to prevent twisting of the sweep frame 250 upon deflection.

FIG. 21B shows another variation of a sweep frame 250. In thisvariation, the sweep frame comprises a plurality of rings 276 spacedapart to create the openings 252 within the sweep frame 250. The ringscan be joined at the spine area 256 via a separate member, a polymercoating, or a separate frame that is ultimately joined to the rings 276.As noted above, the rings can be spaced or vary in size to achieve thedesired pre-determined curvature upon compression of the sweep frame250.

FIG. 21C shows another variation of a sweep frame 250 comprising awoven, coiled, braided or laser cut mesh structure similar to that of avascular stent. The sweep frame 250 structure can comprise a wire orribbon material having a reinforced section to function as the spine256. For example, one side of the stent structure sweep frame 250 can betreated via a coating, fixture or any other means to increase a columnstrength of the section. Accordingly, this area of the stent structuresweep frame 250 functions as a spine 256 of the sweep frame 250.Although the spine 256 of FIGS. 21B and 21C are shown to be along abottom portion of the respective sweep frames, the sweep frames can bemanufactured to provide varying regions of column strength as describedabove.

It is understood that the sweep frames can vary from those that areshown to be any structure that allows for preferential bending androtation when placed within the catheter 120. The sweep frame can befabricated from a variety of materials including a shape memory alloy, asuper elastic alloy, a medical grade stainless steel, or other polymericmaterial, as non-limiting examples. The material of the sweep frame 250can be radiopaque, or can be altered to be radiopaque. In such cases,the physician will be able to observe the degree of articulation of thedevice by observing the curve of the sweep frame 250 prior to cuttingtissue.

5. Steering and Sweeping

FIG. 22A illustrates an example of a variation of a debulking system 100being steered when using a sweep frame 250 and sweep member 270 asdescribed above. The ability to steer the distal portion 122 and cuttingassembly 102 of the system 100 is useful under a number of conditions.For example, when debulking an eccentric lesion in a tortuous vessel asshown, the cutting assembly 102 should be pointed towards the side ofthe vessel 2 having the greater amount of stenotic material 4.Naturally, this orientation helps prevent cutting into the barewall/vessel 2 and focuses the cutting on stenotic tissue 4. When in acurved section of the vessel 2, without the ability to steer, thecutting assembly 102 would tend to bias towards the outside of thecurve. As shown in FIG. 22A, steering allows the cutting assembly 102 topoint inward to avoid accidental cutting of vessel wall 2.

The ability to steer the device 100 also allows for a sweeping motionwhen cutting occlusive material. FIG. 22B shows the rotation of thecutting assembly 102. As shown in FIG. 22C, when the cutting assembly102 deflects relative to the axis of the catheter, rotation of thedeflected portion 102 creates a sweeping motion. It is noted thatrotation or articulation of the cutting assembly 102 also includesrotation or articulation of the catheter to allow the cutting assemblyto deflect relative to an axis of the catheter.

FIG. 22D shows a front view taken along an axis of the vessel toillustrate the sweeping motion causing the cutting assembly 102 to sweepover a larger region than the diameter of the cutting assembly 102. Inmost cases, when articulated, the cutting assembly 102 may be rotated tosweep over an arc, a full circle, or a controlled orbit of multiplecircles.

A user of the system 100 may couple the sweeping motion of the cuttingassembly 102 with axial translation of the catheter 120 for efficientcreation of a larger diameter opening over a length of the occludedvessel. This is because the system 100 is adapted to “sweep” the lumenof materials, the sweep feature allowing the system 100 to create apassage (i.e., diameter) in the lumen having a ratio ranging from about1 (one) to up to about 4 times the diameter of the catheter 120, whichequates to creating a passage having a cross-sectional area of up to 16times greater than the cross-sectional area of the catheter 120. Priorconcentrically operating atherectomy systems are limited in theirability to clear a lumen to their maximum area of cut.

By clearing a larger diameter passage than the diameter of the debulkingdevice, the system 100 creates a clinically relevant increase in size ofthe lumen for blood flow. A clearing system adapted to double thediameter of the lumen (compared to the diameter of the catheter) is ableto quadruple the area available for blood flow. The system is adapted todebulk vessels ranging in diameter from about 1 (one) mm to about 15 mm,although smaller and larger diameter vessels are within the scope of theinvention. In addition, the system 100 is adapted to traverse thecutting assembly across the inner width of the vessel, i.e.,approximately 10 mm.

For example, using the formula (πR²) for the area of a circle, and usinga catheter with a diameter of 2 mm, the area of the catheter is(3.14×1²)=3.14 mm². Now using a cleared cross-sectional area having adiameter of 4 mm, the area of the cleared lumen is (3.14×2²)=12.56 mm²,a factor of four times the cross-sectional area of the catheter. Nowusing a cleared cross-sectional area having a diameter of 8 mm, the areaof the cleared lumen is (3.14×4²)=50.24 mm², a factor of 16 times thecross-sectional area of the catheter.

As seen in FIG. 22E, the catheter 120 has a diameter D1. The ability tosteer and sweep allows the system to clear a lumen having across-sectional diameter greater that the catheter 120, including adiameter D2 (twice the diameter of the catheter), D3 (three times thediameter of the catheter), and D4 (four times the diameter of thecatheter).

The combination of movements described for steering and/or sweeping maybe performed when the device is placed over a guidewire (although notnecessary), for example by the use of a lead screw in the proximalhandle assembly 200 of the system. In another aspect of the systemsdescribed herein, the angle of articulation may be fixed so that thesystem 100 sweeps in a uniform manner when rotated.

FIG. 22C also shows a variation of a debulking system 100 having acatheter body 120 where a first or distal portion 122 of the catheterbody rotates as identified by arrow 280 as the cutting assembly 102sweeps in an arc. The second portion 137 of the catheter remainsstationary. Accordingly, the two part catheter may be joined to permitthe relative movement between sections. The distal portion 122 and/orthe second portion 137 may incorporate a sweep frame 250 and/or sweepmember 270.

As described above, the catheter body 120 can remains stationary whilethe inner sweep frame 250 and sweep member 270 rotate to move thecutting assembly 102 in an arc or orbit within the lumen. Alternatively,the sweep frame 250 and sweep member 270 can rotate with the catheterbody 120 but independently of the cutting assembly 102 and torque shaft114.

Again, the sweep member 270 can be composed of a super-elastic alloy, amedical grade stainless steel, a metal braid sandwiched in a polymericmatrix of such materials as polyethylene (PE), fluoro-polymer (PTFE),nylon, and/or polyether-block amide (PEBAX), polyurethane, and/orsilicone, as non-limiting examples. The sweep member 270 can also bemade of counter wound metal coils. Its distal end is curved and ispreferably made of a material that can withstand high degree of flex andretain its curved shape. Such material may include polymers such as PE,nylon, Polyetheretherketone (PEEK), Nickel Titanium (Nitinol), or springsteel, as non-limiting examples.

As described above, selecting a desired profile for bending, torsion andaxial strength characteristics when designing the catheter body 120and/or sweep member 270 improves the overall function of the debulkingcatheter system 100. Aside from the improved ability to advance thecutting assembly 102 and sweep the cutting assembly in an arc-typemotion, the proper characteristics improve the ability of the physicianto steer the catheter 120. For example, selection of the propercharacteristics reduces the chance that the distal portion 122 of thecatheter 120 rotates more or less than the proximal end or control knob202 on the handle 200.

These characteristics along with the ability to steer the catheter 120provide a system 100 capable of both active and passive steering. Activesteering may incorporate both flexing the distal portion 122 androtating the distal portion to steer through tortuous anatomy. Asdescribed below, this allows the physician to advance the catheter 120with or without a guidewire though tortuous anatomy, and to direct theforward facing cutting assembly 102 to a side wail of a lumen to removeocclusive materials. Passive steering may incorporate advancement of thecatheter 120 until the cutting assembly 102 contacts a bend in thevessel, for example. A simple rotation of the sweep frame 250 to adjustthe first radial side 254 of the sweep frame to the inside radius of thebend (and the spine 256 to the outside radius of the bend) allows theflexible distal portion to naturally or preferentially bend with thevessel, and the catheter 120 may continue to be advanced.

FIGS. 23A through 23H show an advancement of the catheter 120 through atortuous vessel 2, and steering the cutting assembly 102 to a difficultto access treatment site at an inside corner of a vessel bifurcation.FIGS. 23A and 23B show the catheter 120 advanced into the vessel 2 untila bend is contacted. As seen in FIG. 23B, the spine 256 of the unflexedsweep frame 250 is shown on the inside radius of the vessel bend.

FIGS. 23C and 23D show passive steering by simply rotating the sweepframe 250 using the steering controls on the handle 200 to position thefirst radial side 254 of the sweep frame to the inside radius of thebend. This rotation of the sweep frame allows the distal portion tonaturally bend with the vessel, and the catheter 120 may continue to beadvanced. FIGS. 23E and 23F show the catheter 120 advanced to the nextbend in the vessel 2, and the passive steering process repeated torotate the first radial side of the sweep frame 250 to the inside radiusof the bend, allowing the flexible distal portion to naturally bend withthe vessel.

FIGS. 23G and 23H show the catheter 120 being actively steered to accessan inside vessel wall to remove material 4. As can be seen, the controlknob 202 on the handle 200 may be both advanced to deflect the distalportion of the catheter, and the knob 202 may also be rotated to sweepthe flexible distal portion across the lesion 4 for debulking.

In another variation of the invention, the system 100 can improve theability of a physician attempting to navigate a guidewire 128 throughbranching, tortuous or otherwise obstructed anatomy. In the variationshown in FIG. 24A, as a physician navigates a guidewire 128 through theanatomy, the tortuous nature of the anatomy or obstructions 4 within thevessel 2 may prevent advancement of the guidewire 128 as shown. In sucha case, the system 100 of the present invention permits a physician towithdraw the guidewire within the catheter 120 or just distal to thecutting assembly 102 (as shown in FIG. 24B). The system 100 can then beadvanced to a branching point or beyond the tortuous location orobstruction, and articulated (as shown in FIG. 24C) so that thephysician can then advance the guidewire 128 beyond the obstruction,sharp bend, or into the desired branch.

As previously described, the shape of the housing 104 as well as thelocation of the window(s) 106, 107 can be chosen so that when thecutting assembly 102 is substantially aligned with the lesion, orengages it at less than some critical attack angle, it will cuteffectively. However, when pivoted at an angle greater than the criticalangle, the cutting edges or grinding element will not engage the lesion,as shown in FIG. 24D. This means that at large deflections, as thedistal portion of the cutting assembly 102 approaches the vessel wall,it automatically reduces its depth of cut and ultimately will not cutwhen the critical angle is exceeded. For example, the cutter 108 distaltip is blunt and does not cut. As the cutting assembly 102 is deflectedoutward, the blunt tip contacts the vessel and keeps the cutting edgesproximal to the tip from contacting the vessel wall. In addition, theguidewire in combination with the cutting assembly 102 can also act as abuffer to prevent the cutting edges from reaching the vessel wall. Asshown, the portion of the guidewire that extends from the housing 104will bend at a minimum bend radius. This permits a portion of theguidewire closest to the housing to act as a bumper and prevents thecutter 108 and windows 106 from engaging the walls of the vessel. Incertain variations, guidewires with varying bend radii can be selectedto offer varying degrees of protection by spacing the cutter 108 awayfrom the tissue wall.

C. The Handle Assembly

FIG. 25A shows an exploded view of one embodiment of a control handle200 adapted to provide operational controls for the system 100. Asshown, the handle 200 may comprise a handle base portion 201 and acatheter chassis portion 204, both of which may snap or otherwise becoupled together to form the handle 200. Both the handle base 201 andthe catheter chassis 204 may be provided to the user as a sterile,single use, and disposable device, along with the catheter 120 andcutting assembly 102. The two component handle 200 allows for improvedmanufacturability of the individual components, i.e., the handle base201 and the catheter chassis 204, and for isolation of the power (e.g.,power means 236) and rotating means 150 from the catheter chassis 204.It is to be appreciated that the handle 200 may be a single componenthandle, or may be more than two components as well.

1. Handle Base

As seen in FIGS. 25A and 25B, the handle base 201 comprises an ergonomicgrip and functionally convenient access to operational controls of thesystem 100. A first base piece 246 and a second base piece 248 may becoupled together to house elements including on/off means 234, powermeans 236, rotational means 150, and a gear 206 coupled to therotational means. The handle base 201 may be composed of a polymericmatrix of such materials as polycarbonate,acrylonitrile-butadiene-styrene (ABS), polymethyl methacrylate (PMMA),polysulfone, polyethylene ptherethalate (PET), high density polyethylene(HDPE), polyethylene (PE), nylon, polyether-block amide (PEBAX),polyurethane, and/or silicone, as non-limiting examples. As can be seenin FIG. 25B, coupling means 203, e.g., snap, clip, glue, weld, heat, andscrew features, may be provided on the handle base 201 and/or thecatheter chassis 204, and allow for tool free coupling between thehandle base 201 and the catheter chassis 204.

The on/off means 234 may provide a variety of control options forcontrol of the rotation of the cutter 108 including on/off, ramp upand/or ramp down, and/or variable speed, as non-limiting examples. Theon/off means may be any of a variety of known control mechanisms,including a slide switch, pushbutton, and/or potentiometer, asnon-limiting examples.

A power source 236 is desirably coupled to the on/off means 234 and therotating means 150. The power source 236 may comprise a variety of knownpower sources, such as a non-rechargeable battery, a rechargeablebattery, and a capacitor, as non-limiting examples. Desirably, the powersource 236 is adapted to maintain a consistent supply of power to therotating mechanism 150 through all operating conditions, including noload through excessive torque and stall conditions, without excessivelydraining the power source 236. The power source may also have apredetermined amount of operational power, e.g., sufficient power tooperate the system 100 continuously during a procedure for about two toabout three hours, as a non-limiting example.

The rotating means 150, when powered on, provides rotation to a gear206. The gear 206 meshes with a catheter chassis drive gear 207, whichdrives the torque shaft 114 (see FIG. 30). The rotating mechanism 150(e.g., an electric, pneumatic, fluid, gas, or other rotational system),transmits the rotational energy to the torque shaft 114, with the torqueshaft 114 transmitting the rotational energy to the cutter 108.

Variations of the system 100 may include use of a rotating mechanism 150located entirely within the handle 200, as shown. In an alternativevariation, the rotating mechanism 150 may be outside the handle 200and/or outside of the surgical field (i.e., in a non-sterile zone) whilea portion of the system (e.g., the torque shaft 114) extends outside ofthe surgical field and couples to the rotating mechanism 150.

The rotating mechanism 150 may be a motor drive unit. In one workingexample, a motor drive unit operating at 4.5 volts and capable ofproducing cutting speeds up to 25,000 RPM was used. Another example of amotor drive unit included supplying the motor at 6 volts nominal,running at about 12,000 RPM with higher torque. This was accomplished bychanging the gear ratio from 3:1 to 1:1.

In an alternative embodiment, the rotating mechanism 150 may be poweredby a controller that varies the speed and torque supplied to thecatheter 120 and torque shaft 114 to optimize cutting efficiency or toautomatically orbit the cutter 108 and/or cutting assembly 102 usingvariable speed with a fixed flexible distal length of the catheter 120,or providing further orbiting control by controlling the length of thedistal flexible section 122 of the catheter 120). The length of theflexible distal portion 122 (or a predefined portion) may be controlled,i.e., adjusted by including a member 124 either inside or outside thecatheter 120, or both inside and outside the catheter. The member 124may comprise an axially adjustable sheath, wire, or guidewire, forexample, the member 124 having a stiffness greater than the flexibledistal portion. As seen in FIG. 26A, when the sheath 124 is advanceddistally, its added stiffness reduces the flexibility of the flexibledistal portion 122. When the sheath 124 is retracted proximally, thelength of the flexible distal portion may be increased relative to theportion the sheath 124 was retracted (see FIG. 26B).

Orbit control may be induced or enhanced by providing an element ofunbalance, i.e., an asymmetric cutter 108, housing 102, or counterweight123, for example (see FIG. 26C). As the torque shaft 114 rotates thecutter 108, the asymmetric cutter (or housing) causes the cutterassembly 102 to rotate in an arcuate path, i.e., orbital path. Theradius of this arcuate path may be increased by increasing the length ofthe adjustable flexible distal portion 122, and conversely, the arcuaterotational path may be reduced by decreasing the length of theadjustable flexible distal portion.

It is also possible to use feedback control to operate the system 100 ina vessel safe mode, so that the rate of cutting is decreased as thevessel wall is approached. This may be accomplished through speedcontrol, or by reducing the degree to which the cutting blades penetrateabove the housing window 106, 107 by retracting the cutter axiallywithin the housing 104. Feedback variables could be by optical(infrared) or ultrasound transducer, or by other transducers (e.g.,pressure, electrical impedance, etc.), or by monitoring rotational means150 performance. Feedback variables may also be used, in safetyalgorithms to stop the cutter 108, for example, in a torque overloadsituation.

2. Catheter Chassis

As can be seen in FIG. 27, the catheter chassis 204 provides anoperational interface between the handle base 201 and the functions ofthe catheter 120 and cutting assembly 102. The catheter chassis 204provides an extension of the catheter 120, including a strain relief 234positioned at a distal end of the catheter chassis, and providesoperational access to the catheter 120 for cutter assembly steering andsweeping (via the sweep control knob 202, a spring plunger 226, and anindexing cassette 227), cutter rotation (via the catheter chassis gear207 and torque shaft 114), aspiration (via an aspiration port 229),irrigation (via a flush port 129), and a guidewire (via a guidewirelumen 130). A male port and a female port may be provided to identifythe particular function. As can be seen in FIG. 27, coupling means 203may also be also provided on the catheter chassis 204 to allow for toolfree coupling between the handle base 201 and the catheter chassis 204.

a. Cutter Assembly Steering and Sweeping

FIGS. 27 through 28B show the sweep control knob 202, the spring plunger226, and the indexing cassette 227, the combination of which allows forprecise indexing (i.e., position control) of the cutting assembly 102.As shown, the sweep member 270 and torque shaft 114 extend through thesweep control knob 202 and the indexing cassette 227. The sweep controlknob 202 and the indexing cassette 227 may be coupled to the sweepmember 270, so when the sweep control knob 202 is rotated, both thesweep member 270 and the indexing cassette 227 rotate in unison, i.e.,the angle of rotation of the sweep control knob 202 matches the angle ofrotation of the sweep member 270 and the indexing cassette 227. It is tobe appreciated that additional gearing may be included to adjust thespeed of rotation for either or both of the sweep control knob 202 andthe indexing cassette 227.

As seen in FIG. 28A, the indexing cassette 227 may include a pluralityof indexing stops or divots 216. Although this variation of the indexingcassette 227 contains divots, other forms such as grooves or ridges, asnon-limiting examples, may also serve an indexing purpose. The indexingstops 216 may have a twofold benefit. First, they allow incrementalrotational indexing as the physician rotates the control knob 202. Thisincremental indexing is permitted due to the bending, torsion and axialstrength characteristics of the system 100 permitting little or nomisalignment between the distal and proximal ends of the system. Asecondary advantage of the indexing stops 216 is that they allowincremental axial indexing as the physician advances the control knob202 in an axial direction to bend or steer the distal portion 122 of thedebulking catheter system 100 by moving the sweep member 270 in anaxially distal direction.

As shown, any number of positions 218, 220, 222, 224 can be created onthe indexing cassette 227. As shown in FIG. 28A, a spring plunger 226can provide tactile feedback to the physician as the control knob 202rotates. Once the physician desires to bend or steer the debulkingsystem 100 by moving the knob 202 in an axial direction 228, thephysician desirably may feel movement of the knob 202 (via the springplunger 226) into the second 220 and third 222 stop positions (forexample), as shown in FIG. 28B.

As shown, the control knob 202 may also include an orientation marker214 that may correspond to the weakened section of the sweep frame 250(not shown). The orientation marker 214 could also correspond to a sideof the sweep frame 250 that is opposite to a spine 256 of the sweepframe. Because the orientation marker 214 may be aligned with the sweepframe in such a manner, the physician knows that the catheter 120 wouldbend in a direction corresponding to the orientation marker 214. Thisallows the physician to identify the orientation of the cutting assembly102 as it sweeps within the body lumen by observing the orientation ofthe orientation marker 214 as the physician rotates the sweep controlknob 202. Even if the one-to-one relationship may be lost, the indexingknob 202 adds a fine visual control to direct the distal portion 122 indefined steps or increments. This control can be useful because thephysician can direct the cutter 108 within the immediate vicinity towork on areas that need to be resected, versus losing position due toexcessive movement. An atherectomy or tissue debulking system havingfeatures that allow pushability as well as torsional strength allow thephysician greater feedback and control when trying to steer the cuttingassembly 102 towards a desired treatment site within the body.

As described above, the catheter chassis 204 includes a sweep controlknob 202 coupled to the sweep member 270. The sweep control knob 202 canaxially advance the sweep member 270 to cause deflection of the sweepframe 250 and distal portion 122 of the catheter 120. In addition, thesweep control knob 202 can rotate independently relative to the torqueshaft 114 and rotatable cutter 108 in the cutting assembly 102.

As shown in FIG. 29A, distal movement of the sweep control knob 202advances the sweep member 270 to deflect the catheter tip and cuttingassembly 102. The degree of the deflection is controlled by the amountthe sweep control knob 202 is advanced. The axial advancement of thesweep member 270 is limited by the maximum deflection of the sweep frame250. To allow the cutter assembly 102 and distal portion 122 to bestraight and undeflected, the sweep member 270 may be withdrawnproximally by the sweep control knob 202. This may cause removal of theaxial force from the sweep frame 250 (in some variations, the sweepframe can be set in a straight configuration). In other variations, thesweep control knob 202 retracts the catheter body relative to the sweepframe 250 and/or member 270 to deflect the catheter tip and cuttingassembly 102.

As shown in FIG. 29B, the sweep control knob 202 can be rotated to sweepthe cutting assembly 102 in an arc manner. Although, sweeping of thecutting assembly 102 can also occur via manual operation, i.e., rotationof the handle 200. Variations of the handle 200 include sweep members270 that can be selectively coupled to a sweep mechanism i.e., a sweepcontrol motor (not shown), to activate an automated rotation. This mayallow the physician to have a smooth, continuous, automated means tosweep the cutter assembly 102 without any manual effort.

The systems, devices, and methods of the present invention allow aphysician to accurately determine the rotation of the cutting assembly102 since the rotation of the cutting assembly closely corresponds tothe rotation of the control knob 202. Such close correspondence is notavailable unless the catheter body 120 and/or sweep member 270 hassufficient bending, torsion and axial strength characteristics, aspreviously discussed. Accordingly, a further aspect of the system 100occurs when these catheter bodies/sweep members are coupled to a handle200 having a sweep control knob 202 that enables indexing and monitoringof the orientation of the cutter assembly 102. Clearly, this one-to-onerelationship can be lost when the distal portion 122 or cutting assembly102 encounters sufficient resistance against or within a lesion,occlusion, or diseased tissue. However, in such cases, the system 100 isstill able to debulk tissue and perform its function even though theresponse may not be one-to-one. In any case, the ability to maintain anear one-to-one relationship and minimize rotational misalignmentbetween the proximal and distal portions of the system 100 allows forsteering of the debulking system 100 towards the treatment site.

b. Cutter Rotation and Aspiration

FIG. 30 shows the motor gear 206 adapted for rotation of the catheterchassis gear (torque shaft gear) 207, with the torque shaft 114 passingthrough and coupled to the torque shaft gear 207. A transfer propeller212 may be rigidly attached to the torque shaft 114 to pump aspiratedtissue debris 8 from the catheter 120 out into an attached aspirationreservoir. The torque shaft 114 may include one or more bearings 210. Aseal 211 adjacent to the bearing 210 prevents aspirated tissue debrisfrom leaking proximally through the bearing 210.

As previously described, the torque shaft 114 may have conveying membersor helical grooves 118 on its outer diameter and/or within the centralguidewire lumen 130. During a procedure run, a motor 150 drives the gear206 to rotate. This causes rotation of the drive shaft 208, the transferpropeller 212, the torque shaft 114, and the cutter 108 all in the samerotational sense. Thus the cutter assembly 102 effectively cuts plague 8and may further grind the plaque into smaller pieces, and then drivesthe debris 8 back into the helical groove 118 on the torque shaft 114.The rotating helical grooves 118 winds the debris back into the catheterchassis 204, and the debris is then transferred to an aspirationreservoir by the transfer propeller 212. The propeller 212 can take theform of a screw or a series of circumferentially arranged angled fanblades, for example. The cutter 108 may be rotated at speeds of rangingfrom about 8,000 rpm to about 25,000 rpm, although higher and lowerspeeds are within the scope of the invention. An alternative designwould have the aspiration reservoir built into the catheter hub 204and/or handle base 201.

The system 100 may also include a vacuum source or pump 152 to assist inevacuation of debris created by operation of the device. Any number ofpumps or vacuum sources may be used in combination with the system. Forexample, a peristaltic pump may be used to drive materials from thesystem and into a waste container. FIG. 25A also shows the system 100coupled to a fluid source 154. As with the rotating mechanism 150, thevacuum source and/or fluid source may be coupled to the system 100 e.g.,at the handle 200, from inside or outside the surgical field.

c. Irrigation

FIG. 27 shows the catheter chassis 204 as having a flush port 129. Theflush port 129 provides a means for injecting a fluid such asheparinized saline or any other medicine into the catheter body 120 andcatheter chassis 204 to keep blood and tissue debris from clogging thespace between components in the device. The flush port 129 can also helplubricate moving components within the catheter 120. One desirable fluidpath is along the length of the catheter 120 in the space between thecatheter body 120 and sweep member 270. Drugs or fluids can beintroduced via the flush port 129 for flow out of one or more openings131 near the distal portion 122 or cutting assembly 102. Drugs flushingout near the cutting assembly 102 can then infuse into the vessel wall.Using thrombus-inhibiting, stenosis-inhibiting, and/or anti-inflammatorydrugs, for example, may help prevent restenosis after a thrombectomy oratherectomy procedure. Possible drugs may include rapamycin and analogssuch as everolimus, biolimus, and sirolimus; M-prednisolone; interferony-lb; leflunomide; mycophenolic acid; mizoribine; cyclosporine;tranilast; biorest; tacrolimus; taxius; clopidogrel; rapamycin;paclitaxel; botox; lydicane; Retin A Compound; glucosamine; chondroitinsulfate; or geldanamycin analogs 17-AAG or 17-DMAG, as non-limitingexamples.

A wide range of other bioactive materials can be delivered by the system100. Additional examples include heparin, covalent heparin, or anotherthrombin inhibitor, hirudin, hirulog, argatroban,D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or anotherantithrombogenic agent, or mixtures thereof; urokinase, streptokinase, atissue plasminogen activator, or another thrombolytic agent, or mixturesthereof; a fibrinolytic agent; a vasospasm inhibitor; a calcium channelblocker, a nitrate, nitric oxide, a nitric oxide promoter or anothervasodilator; Hytrin® or other antihypertensive agents; an antimicrobialagent or antibiotic; aspirin, ticlopidine, a glycoprotein IIb/IIIainhibitor or another inhibitor of surface glycoprotein receptors, oranother antiplatelet agent; colchicine or another antimitotic, oranother microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid oranother antisecretory agent; cytochalasin or another actin inhibitor; ora remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotideor another agent for molecular genetic intervention; methotrexate oranother antimetabolite or antiproliferative agent; tamoxifen citrate,Taxol® or the derivatives thereof, or other anticancer chemotherapeuticagents; dexamethasone, dexamethansone sodium phosphate, dexamethasoneacetate or another dexamethasone derivative, or anotheranti-inflammatory steroid or non-steroidal anti-inflammatory agent;cyclosporin or another immunosuppressive agent; trapidal (a PDGFantagonist), angiopeptin (a growth hormone antagonist), angiogenin, agrowth factor or an antigrowth factor antibody, or another growth factorantagonist; dopamine, bromocriptine mesylate, pergolide mesylate oranother dopamine agonist; ⁶⁰Co(5.3 year half life), ¹⁹²Ir(73.8 days),³²P(14.3 days), ¹¹¹In(68 hours), ⁹⁰Y(64 hours), ^(99m)Tc(6 hours) oranother radiotherapeutic agent; iodine-containing compounds,barium-containing compounds, gold, tantalum, platinum, tungsten oranother heavy metal functioning as a radiopaque agent; a peptide, aprotein, an enzyme, an extracellular matrix component, a cellularcomponent or another biologic agent; captopril, enalapril or anotherangiotensin converting enzyme (ACE) inhibitor; ascorbic acid, alphatocopherol superoxide dismutase, deferoxamine, a 21-aminosteroid(lasaroid) or another free radical scavenger, iron chelator orantioxidant; a ¹⁴C—, ³H—, ¹³¹I—, ²¹P— or ³⁶S-radiolabelled form or otherradiolabelled form of any of the foregoing; estrogen or another sexhormone; AZT or other antipolymerases; acyclovir, famciclovir,rimantadine hydrochloride, ganciclovir sodium, Norvir, Crixivan, orother antiviral agents; 5-aminolevulinic acid,meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine,tetramethyl hematoporphyrin, rhodamine 123 or other photodynamic therapyagents; an IgG2 Kappa antibody against Pseudomonas aeruginosa exotoxin Aand reactive with A431 epidermoid carcinoma cells, monoclonal antibodyagainst the noradrenergic enzyme dopamine betahydroxylase conjugated tosaporin or other antibody targeted therapy agents; gene therapy agents;and enalapril and other prodrugs; Proscar®, Hytrin® or other agents fortreating benign prostatic hyperplasia (BHP) or a mixture of any ofthese; and various forms of small intestine submucosa (SIS).

III. Additional System Features

A. Energy Delivery

The construction of the cutting assembly 102 can provide for additionalmodes of energy delivery. For example, when the system 100 excisestissue in vascularized regions excessive bleeding can occur (e.g., lungbiopsy and excision). Accordingly, energy can be delivered to the targetsite via a conductive cutter assembly (i.e., the housing 104 and/or thecutter 108, for example). Sound energy (ultrasound), electrical energy(radio frequency current), or even microwaves can be used for thispurpose. These energy sources delivered through the cutter assembly 102can also be used to denature tissue (collagen), shrink tissue, or ablatetissue. Optionally, a guidewire, if used, may be removed and replacedwith a cable for UV energy delivery and/or to deliver radiationtreatments, all as a standalone or combination treatment.

B. Distal Portion Visualization

FIGS. 31A and 31B show variations of a sweep frame 250 having avisualisation feature 284 that permits a physician to determineorientation and direction of articulation of the cutting assembly 102when the device is viewed under non-invasive imaging, e.g., fluoroscopy.FIG. 30A shows one variation of the visualisation feature 284 as being anotch or opening 284 on a side of the sweep frame 250 that isperpendicular to the direction in which the frame bends. In one example,the visualization mark is placed 90 degrees relative to the spine 256.Although the feature 284 is shown on the right side of the sweep frame250, any side may be used so long as the location and orientation of thefeature 284 conveys to the physician the orientation and direction ofbend of the sweep frame 250 via non-invasive imaging.

FIG. 31B illustrates another variation of an orientation feature 284comprising a marking substance (e.g., a radiopaque additive and/or ahighly radiopaque metal deposited on the sweep frame 250, asnon-limiting examples). In any case, the visualisation feature 284 mustprovide sufficient contrast against the frame 250 when viewed in anon-invasive imaging modality. These visualisation means may alsoinclude arrangements such as a notch, opening, tab, protrusion, ordeposition, for example.

As shown, both visualization features 284 are on the right-hand side ofthe sweep frame 250 when the spine 256 of the frame 250 is directlyadjacent to the physician. In this position, articulation of the sweepframe (that occurs in a direction away from the spine), causes the sweepframe 250 to deflect away from the physician. Accordingly, when thephysician observes the visualization marks 284 to the right of thedevice, the physician will know that flexure of the sweep frame 250 willoccur directly away from the physician. Clearly, the present inventionincludes any number of visualization features or placement of suchfeatures on any portion of the sweep frame 250 or other portions of thedistal section 122, so long as the physician will be able to determinethe orientation and direction of bend of the sweep frame 250 fromviewing the visualisation mark(s) 284.

C. Flushing Solutions

Infusing solutions (e.g., flushing) into the target treatment site maybe desirable. Infused cool saline can prevent heating of blood and othertissue, which reduces the possibility of thrombus or other tissuedamage. Heparinized saline can also prevent thrombus and thin out theblood to help maximize effectiveness of aspiration. The flush can alsoinclude thrombus-inhibiting, stenosis-inhibiting or anti-inflammatorydrugs such as those listed above. This may help to prevent restenosisand may result in better long term patency. The flush may includeparalytics or long-acting smooth muscle relaxants to prevent acuterecoil of the vessel. FIGS. 32A to 32C illustrate variations of flushingout the system 100. The flush can be infused through the guidewire lumen130 (FIG. 32A), a side lumen 132 in the catheter body 120 (FIG. 32B),and/or sideports 127 in the guidewire 128 (FIG. 32C).

Flush can come out of a port at the distal end of the cut tar 108pointing the flush proximally to facilitate aspiration. Alternatively,by instilling the flush out the distal end of the cutter housing 104over the rounded surface, the flow may be directed rearward by theCoanda effect. The restenosis-inhibitors can be carried by microcapsuleswith tissue adhesives or velcro-like features on the surface to stick toinner vessel surface so that the drug adheres to the treatment site, andto provide a time-release controlled by the resorption or dissolving ofthe coating to further improve efficacy. Such velcro-like features maybe constructed with nanoscale structures made of organic or inorganicmaterials. Reducing the volume of foreign matter and exposing remainingtissue and extracellular matrix to drugs, stimulation, or sensors canmake any of these techniques more effective.

Another way to infuse fluid is to supply pressurized fluid at theproximal portion of the guidewire lumen 130 (e.g., gravity and/ orpressure feed with an intravenous bag, for example). A hemostatic sealwith a side branch is useful for this purpose; tuohy-borst adapters areone example of a means to implement this.

Balancing the relative amount of infusion versus fluid volume aspiratedallows control over the vessel diameter; aspirating more fluid than isinstilled will evacuate the vessel, shrinking its diameter, and allowcutting of lesion at a greater diameter than the atherectomy catheter.This has been a problem for certain open cutter designs that useaspiration, because the aggressive aspiration required to trap theembolic particles evacuates and collapses the artery around the cutterblades. This is both a performance issue because the cutter can bog downfrom too high torque load, and the cutter can easily perforate thevessel. The cutter assembly 102 designs described herein obviates bothproblems, and further requires less aggressive aspiration to beeffective, giving a wider range of control to the user.

D. Rapid Exchange

FIG. 33 illustrates a variation of a system 100 configured for rapidexchange. As shown, the system 100 includes a short passage, lumen, orother track 136 for the purpose of advancing the device 100 over theguidewire 128. However, the track 136 does not extend along the entirelength of the catheter 120. Moreover, an additional portion of the track136 may be located at a distal end 134 of the catheter 120 to center theguidewire 128.

This feature permits rapid decoupling of the system 100 and guidewire128 by merely holding the guidewire still and pulling or pushing thesystem 100 over the guidewire. One benefit of such a feature is that theguidewire 128 may remain close to the procedure site while beingdecoupled from the system 100. Accordingly, the surgeon can advanceadditional devices over the guidewire 128 and to the site in a rapidfashion. This configuration allows for quick separation of the catheter120 from the guidewire 128 and introduction of another catheter over theguidewire since most of the guidewire is outside of the catheter.

E. Over the Wire

As shown in FIG. 34, centering the tip of the cutting assembly 102 overthe guide wire 128 improves the control, access and positioning of thecutting assembly 102 relative to a body lumen or vessel 2. To accomplishthis, the cutting assembly 102 can have a central lumen 130 toaccommodate a guide wire 128. Variations of the system 100 include acentral guide wire lumen 130 that may run the length of the catheter 120through all or some of the central components including the torque shaft114, the cutter 108, and the handle 200. As noted above, the guidewire128 can be affixed to the housing 104 or other non-rotational componentof the cutting assembly 102. In such a case, the guidewire 128 maypreferably be a short segment that assists with navigation of the devicethrough an occluded portion of a body lumen. However, the system 100 canalso operate without a guidewire since the distal portion 122 issteerable like a guidewire.

F. Combination Treatments

The devices, systems, and methods of the present invention may also beused in conjunction with other structures placed in the body lumens. Forexample, as shown in FIG. 35, one way to protect the vessel and alsoallow for maximum plague volume reduction is to deploy a protectivestructure such as a stent, thin expandable coil or an expandable mesh182 within a lesion. As this structure expands after deployment, thethin wire coil or the struts push radially outward through the plaqueuntil it becomes substantially flush with the vessel wall. Thisexpansion of thin members requires minimal displacement of plaque volumeand minimizes barotrauma produced in balloon angioplasty or balloonexpanded stent delivery. Once the protective structure 182 has expandedfully, atherectomy can be performed to cut away the plaque 4 inside thevessel 2 to open up the lumen. The vessel wall is protected by theexpanded structure 182 because the structure members (coil or struts)resist cutting by the atherectomy cutter 108, and are disposed in a waythat they cannot invaginate into the cutter housing 104 (and thereby begrabbed by the cutter 108). It is also possible to adjust the angle ofthe windows 106 on the guarded cutter housing 106 so that they do notalign with the struts or coils. The adjustment to orientation may beaccounted for in the coil or strut design, in the cutter housing design,or both.

Furthermore, the protective member 182 can be relatively flexible andhave a low profile (i.e., thin elements), so that it may be left inplace as a stent. Because the stent in this case relies mainly uponatherectomy to restore lumen patency, it may be designed to exert farless radial force as it is deployed. This allows usage of greater rangeof materials, some of which may not have as high of stiffness andstrength such as bioresorbable polymers and metal alloys. Also, thisallows a more resilient design, amenable to the mechanical forces in theperipheral arteries. It also minimizes flow disruption, to minimizehemodynamic complications such as thrombosis related to the relativelylow flows found in the periphery. It is also possible to performatherectomy prior to placing the protective structure 182, whether ornot atherectomy is performed after placing the structure.

As described, it may be advantageous to couple atherectomy withstenting. By debulking the lesion, a lesser radial force is required tofurther open the artery and maintain lumen diameter. The amount ofdebulking can be tuned to perform well in concert with the mechanicalcharacteristics of the selected stent 182. For stents that supplygreater expansion and radial force, relatively less atherectomy isrequired for satisfactory result.

An alternative treatment approach is to debulk the lesion substantially,which will allow placement of a stent optimized for the mechanicalconditions inherent in the peripheral anatomy. In essence, the stent cansupport itself against the vessel wall and supply mild radial force topreserve luminal patency. The stent may be bioresorbable, and/or drugeluting, with the resorption or elution happening over a period for daysto up to 12 weeks or more, as a non-limiting example. A period of 4 to12 weeks matches well with the time course of remodeling and return tostability as seen in the classic wound healing response, and inparticular the known remodeling time course of arteries following stentprocedures.

In addition, the stent geometry can be optimized to minimise thrombosisby inducing swirl in the blood flow. This has the effect of minimizingor eliminating stagnant or recirculating flow that leads to thrombusformation. Spiral construction of at least the proximal (upstream)portion of the stent 182 may achieve this. It may also be beneficial toensure that flow immediately distal to the stent does not create anystagnant or recirculation zones, and swirl is a way to prevent this aswell.

It is also possible to use the devices, systems, and methods describedherein to restore patency to arterial lesions by debulking in-stentrestenosis. FIG. 35 shows the system 100 removing lesions within a stentor coil.

The system 100 may be further configured with a balloon 138 or othermechanism proximal to the cutter, for adjunctive angioplasty, stent,and/or drug delivery (see FIGS. 40A and 40B for example). Incombination, the system 100 may first debulk a vessel with the mechanism138 undeployed (see FIG. 40A), and then deploy a mechanism, such as drugcoated balloon 138, because the balloon drug delivery may be moreuniform and effective drug delivery compared to drug delivery within anuntrimmed vessel (see FIG. 40B). The system 100 may also deliver drugtherapy through the guidewire lumen 130. For example, a fluid may bedelivered through the lumen, and with the cutting assembly 102 steeredtoward plaque and/or a wall of the vessel, a jet of drug therapy may bedelivered to the target site.

The system 100 may optionally be configured to deliver self-expandingstents. This feature provides convenience to the user and greaterassurance of adjunctive therapy at the intended location whereatherectomy was performed.

G. Additional System Features

Additional components may be incorporated into the devices, systems, andmethods described herein. For example, it can be desirable toincorporate sensors and/or transducers 144 into and/or onto the distalportion 122 of the catheter body 120 and/or the cutting assembly 102 tocharacterize the plague and/or to assess plague and wall thickness andvessel diameter for treatment planning (see FIGS. 41A and 41B).Transducers 144 may also be desired to indicate the progression ofdebulking or proximity of the cutter 108 to a vessel wall. For example,pressure sensors 144 mounted on the catheter housing 104 or cutter 108can sense the increase in contact force encountered in the event thatthe housing is pressed against the vessel wall. Temperature sensors 144can be used to detect vulnerable plaque. Ultrasound transducers 144 canbe used to image luminal area, plaque thickness or volume, and wallthickness. Electrodes 144 can be used for sensing the impedance ofcontacted tissue, which allows discrimination between types of plaqueand also vessel wall. Electrodes can also be used to deliver impulses ofenergy, for example to assess innervation, to either stimulate orinactivate smooth muscle, or to characterize the plaque (composition,thickness, etc.). For example, transient spasm may be introduced tobring the vessel to a smaller diameter making it easier to debulk, thenreversed either electrically or pharmaceutically. Electrical energy mayalso be delivered to improve the delivery of drugs or biologic agents,by causing the cell membrane to open in response to the electricstimulation (electroporation). One method of characterization byelectrical measurement is electrical impedance tomography.

Optical coherence tomography (OCT) can be used to make plaque and wailthickness measurements. As seen in FIG. 42, an OCT device 146 may beprovided in conjunction with the cutter assembly 102, for example. TheOCT device 146 may also be introduced into the target area through theguidewire lumen 130. The steerable distal portion 122 allows forcontrolled viewing of not only the center portions of the vessel, butthe sidewalls can be imaged as well. The forward cutting assembly 102combined with the OCT device 146 allows for imaging of the targetedtreatment area before, during, and after debulking the vessel. A simplesaline flush may be used to reduce absorption of the optical waves inthe blood, to improve imaging of the viewing area.

IV. Lower Extremity Anatomy

FIG. 36 shows the arteries of the pelvis and the lower limbs. Aspreviously described, the devices, systems, and methods are well suitedfor use in this peripheral region. The main artery extending from thepelvis is the iliac artery, with the internal iliac artery supplyingmost of the blood to the pelvic viscera and wall.

The external iliac arteries diverge through the greater (false) pelvisand enter the thighs to become the right and left femoral arteries. Bothfemoral arteries send branches superiorly to the genitals and the wailof the abdomen. The profunda femoris artery (also known as the deepfemoral artery) branches off of the proximal superficial femoral arterysoon after its origin. The profunda travels down the thigh closer to thefemur than the femoral artery, running between the pectineus and theadductor longus muscles.

The femoral passes through the hunter's canal and continues down themedial and posterior side of the thigh posterior to the knee joint, avery flexible region, where it becomes the popliteal artery. Between theknee and ankle, the popliteal runs down on the posterior aspect of theleg and is called the posterior tibial artery. Inferior to the knee, theperoneal artery branches off the posterior tibial to supply structureson the medial side of the fibula and calcaneus bones (both not shown).In the calf, the anterior tibial artery branches off the popliteal andruns along the anterior surface of the leg. At the ankle it becomes thedorsalis pedis artery. At the ankle, the posterior tibial divides intothe medial and lateral plantar arteries. The lateral plantar artery andthe dorsalis pedis artery unite to form the plantar arch. From thisarch, digital arteries supply the toes.

A. Representative Uses of the Atherectomy System

The debulking system 100 as described makes possible a single insertionof the catheter 120 for providing treatment of occluded body lumens,including the removal of lesions from arteries in the lower extremity,the single insertion of the catheter 120 including removal of thedebulked material. The debulking system 100 is adapted to performdebulking in a wide range of vessels, including arteries in the upperand lower extremity, representative examples of which will be describedfor the purpose of illustration.

The system 100 may be used in a wide range of artery configurationsfound in the leg, including tortuous and straight, and may be used inshort and long vessels, i.e., 20 cm or longer. The system 100 is wellsuited for use above the knee up to the common femoral artery, althoughit is to he appreciated that the system may be used in arteries proximalto the common femoral artery. The system is also well suited for use inarteries below the knee, and may be used all the way down to the ankleand/or foot.

A wide range of vessel sizes may be found in the leg, all of which maybe accessible for use with the system 100. A typical diameter for thecatheter 120 ranges from about 1.0 mm to about 3.0 mm, providing accessfor a wide range of target sites. For example, the common femoral arteryranges in diameter between about 6 mm to about 7 mm; the superficialfemoral artery ranges between about 4 mm to about 7 mm; the poplitealartery ranges between about 3 mm to about 5 mm; and the tibial arteryranges between about 2 mm to about 4 mm.

The profunda and the common femoral arteries have been found to be lessthan desirable areas for stenting and/or ballooning, for example,because this area should remain available for bypass graft of thefemoral artery. The devices, systems, and methods for atherectomy inthese regions provide a good solution for debulking.

A variety of options exists for access to target sites within the leg.Based on access and desired target area, a variety of possible workinglengths exist for the system 100. For example, four size options may beavailable: 1) ipsilateral (same side) access and down to a site abovethe knee; 2) ipsilateral access and down to a site below the knee; 3)contralateral (opposite side) access and across and down to a site abovethe knee; and 4) contralateral access and across and down to a sitebelow the knee. The size options take into account access from variousanatomical access points such as femoral artery, brachial artery, etc.

A typical working length of the system 100 ranges from about 110 cm toabout 130 cm for ipsilateral approaches (see FIG. 37), and from about130 cm to about 150 cm for contralateral approaches (see FIG. 38)possibly extending below the knee. Contralateral access may be desiredand/or necessary because the introducer may be blocking the treatmentarea.

V. Instructions for Use of the System

The instructions for use 404 can direct use of the catheter-based system100 via a peripheral intravascular access site, such as in the femoralartery, optionally with the assistance of image guidance. Image guidanceincludes but is not limited to fluoroscopy, ultrasound, magneticresonance, computed tomography, optical coherence tomography, orcombinations thereof.

The system 100 may be used in a procedure that takes less time thanprior debulking devices, e.g., a debulking procedure may be performed in45 minutes or less. In addition, only a single insertion of the system100 is needed for a procedure (i.e., no catheter exchange), as comparedto requiring multiple catheter exchanges for prior debulking devices.This is because the system 100 is adapted to “sweep” the lumen ofmaterials, the sweep feature allowing the single system 100 to create apassage in the lumen having a ratio ranging from about one to up toabout four times the diameter of the catheter 120. The system is adaptedto debulk vessels ranging in diameter from about one mm to about ten mm,although smaller and larger diameter vessels are within the scope of theinvention.

Prior to use, a clinician identifies the particular vascular region towhich a prescribed treatment using the atherectomy system 100 will beapplied. The site is prepped for vascular access to the artery to betreated. The debulking system 100 may be removed from the sterilepackage. The distal portion 122 of the system 100 is inserted into theartery and advanced to the target site. A guidewire may also be usedduring this phase of the procedure. The steering capabilities of thesystem 100 may be used to assist the surgeon to steer the system throughtortuous vessels to the target site. Once the cutting assembly is at thetarget site, the surgeon powers the system 100 by pressing or activatingthe on/off means 234. The surgeon is able to control the operation ofthe system 100 with only one hand on the ergonomic handle 200. With thecutter 108 rotating at a desired RPM, under image guidance, the surgeonslowly advances the catheter 120 distally to cut and remove plaque. Thesurgeon is able to use the sweeping capabilities of the system 100 tocreate a sweeping motion of the cutting assembly 102 to sweep and cutthe lesion in an arcing path, thereby producing a diameter clearing inthe vessel that may be up to four times the diameter of the catheter120. As the cutting is taking place, system first cuts the material withthe first cutting edge 112, and then further cuts or grinds the cutmaterial into smaller pieces for easier transportation through thelength of the catheter 120, through the catheter chassis 204, and outthe aspiration port 209 to a container.

Depending on the desired treatment, the system 100 may be used forcombination treatments as previously described. For example, theguidewire, if used, may be removed and replace with additional treatmentoptions, such as UV radiation. Or, the flushing system as previouslydescribed may be used to infuse drugs into the target site, possiblybefore, during, or after the debulking procedure.

After the lesion has been removed from the vessel, the surgeon powersdown the system, and slowly withdraws the catheter from the vessel. Theentry location is cleaned and bandaged. The system 100 may be disposedof per hospital or facility guidelines.

Additional or alternative instructions may describe various proceduresand uses of the system. For example, the instructions for use maydescribe the use of the catheter, the instructions comprising theoperations of introducing the catheter assembly into the blood vesseland positioning the tissue cutting assembly at our near a site in needof tissue debulking, manipulating the tissue removal assembly to debulktissue in the blood vessel, creating a cleared tissue diameter withinthe vessel of at least two times the diameter of the tissue removalassembly, and removing the cleared tissue.

Instructions for use describing the use of the catheter may alsocomprise the operations of introducing the catheter assembly into theblood vessel and positioning the tissue cutting assembly at or near asite in need of tissue debulking, manipulating the deflection controldevice thereby deflecting a distal portion of the catheter, andmanipulating the rotation control device thereby rotating the distalportion of the catheter in an arcuate path.

Additional instructions for use describing the operation of the cathetermay comprise introducing the catheter assembly into the blood vessel andpositioning the tissue cutting assembly at or near a site in need oftissue debulking, deflecting the bending frame in a direction of a firstradial side of the bending frame by moving a sweep member at or near theproximal end of the catheter, thereby causing the tissue cuttingassembly to deflect in the direction of the first radial side, rotatinga torque shaft extending through the catheter and coupled to at leastthe rotatable cutter, moving the sweep member independently of thetorque shaft for rotating the bending frame and causing the tissuecutting assembly to sweep in an arcuate path relative to an axis of aproximal end of the bending frame, and removing the occlusive material.

Additional instructions for use describing the operation of the cathetermay comprise providing a catheter sized and configured to be introducedinto the blood vessel, the catheter including a tissue cutting assemblyat or near a distal end of the catheter, the tissue cutting assemblyincluding a rotatable cutter for debulking the tissue from the bloodvessel, providing a control handle coupled to the catheter assembly, thecontrol handle including steering means for steering the tissue cuttingassembly, introducing the catheter into an iliac artery, advancing thecatheter into a femoral artery, a profunda femoris artery, an artery inthe hunter's canal, a popliteal artery, a tibial artery, a peronealartery, a dorsalis pedis artery, a medial plantar artery, a lateralplantar artery, or a digital artery, positioning the tissue cuttingassembly at or near a target site in the femoral artery, the profundafemoris artery, the artery in the hunter's canal, the popliteal artery,the tibial artery, the peroneal artery, the dorsalis pedis artery, themedial plantar artery, the lateral plantar artery, or the digitalartery, operating the steering means by applying a first force to thesteering means, the first force causing the distal portion of thecatheter to deflect in a radial direction, operating the steering meansby applying a second force to the steering means, the second forcecausing the distal portion of the catheter to rotate in an arcuate pathwhile the distal portion is deflected in the radial direction, advancingthe catheter distally to sweep the target site thereby allowing therotatable cutter to debulk tissue from the target site in the arcuatepath, and removing the debulked tissue from the target site, therebytreating the blood vessel.

VI. System Kit

As FIG. 39 shows, the system 100 and devices as just described can beconsolidated for use in a multiple piece functional kit 400. It is to beappreciated that the system 100 and devices are not necessarily shown toscale.

The kit 400 can take various forms. In the illustrated embodiment, thekit 400 comprises an individual package comprising a sterile, wrapped,peel-open assembly. The kit 400 may include an interior tray 402 made,e.g., from die cut cardboard, plastic sheet, or thermo-formed plasticmaterial, which hold the contents. The kit 400 also preferably includesinstructions or directions 404 for using the contents of the kit 400 tocarry out a desired procedure, as described above.

The kit 400 provides the main components of the debulking system 100 asdescribed, including the cutting assembly 102, the catheter 120, and thehandle 200, assembled and ready for use. In one embodiment the handlebase 201 may not be coupled to the catheter chassis 204. The remainingcomponents may be optional ancillary components used in the deploymentof the system 100, e.g., a conventional vascular access sheath 406; aconventional (e.g., 0.014 inch) guide wire 128; and bags containingheparinized saline for catheter flushing and contrast for angiography408.

The instructions for use 404 can, of course vary. The instructions foruse 404 can be physically present in the kit, but can also be suppliedseparately. The instructions for use 404 can be embodied in separateinstruction manuals, or in video or audio recordings. The instructionsfor use 404 can also be available through an internet web page.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

We claim:
 1. A method of treating a region of a blood vessel comprising:identifying a first arterial site at or below the knee having occlusivematerial forming a lesion; introducing a distal end of a catheter at anaccess site above the knee, wherein the catheter comprises a cuttingassembly at the distal end of the catheter and a slotted tube comprisinga first slot pattern in a proximal portion of the catheter and a secondslot pattern in a distal portion of the catheter, the cutting assemblycomprising: a distal cutter with one or more fluted cutting edges; acutting core adapter having a number of fluted cutting edges greaterthan that of the distal cutter; and a housing comprising a forwardcutting surface, wherein the cutter is located concentrically within thehousing; advancing the cutting assembly to the first arterial site;rotating the distal cutter of the cutting assembly to remove occlusivematerial from the lesion; cutting or grinding the occlusive materialinto smaller pieces using the cutter core adapter; and removing theocclusive material through an aspiration port.
 2. The method of claim 1wherein the catheter comprises a torque shaft, wherein the torque shaftis connected to the cutting assembly.
 3. The method of claim 2 whereinthe catheter comprises a lumen extending through the torque shaft andthe cutting assembly accommodating passage of a guide wire.
 4. Themethod of claim 2 wherein the torque shaft has at least one helicalconveyor member wound about an exterior such that rotation of the torqueshaft conveys material across a length of the torque shaft.
 5. Themethod of claim 1 wherein introducing the distal end of the cathetercomprises advancing the distal end over a guide wire.
 6. The method ofclaim 1 wherein the catheter further comprises a burr located on adistal tip of the cutter.